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Will the FDA Recall Birth Control Products Yasmin & Ocella?

Paul Kiesel — Tue, 25 Aug 2009 18:29:18 GMT

After a birth control pill spent months in the spotlight during commercials aimed at correcting misrepresentations about it, the pill is now at the center of a St. Clair County lawsuit.

Kerry Sims filed a lawsuit Aug. 18 against Bayer and Walgreens, alleging her ingestion of the birth control pill Yasmin, which is also known as Yaz, caused her to experience a blood clot in her lung and infection surrounding the clot.

The suit comes after a commercial warning of some fallacies about the pill repeatedly ran on television for months.

"You may have seen some Yaz commercials recently that were not clear," the ad says. "The FDA wants us to correct a few points in those ads."

It goes on to say Yaz is used to treat the less serious premenstrual dysphoric disorder and moderate acne, not the more serious premenstrual syndrome or mild acne as Bayer once advertised.

But the $20 million Bayer spent on the commercial is not enough for Sims, who says the company failed to warn her about the pill's dangers before she started taking it.

"Plaintiff Kerry Sims reasonably relied upon Defendants' representations to her and/or her healthcare providers that Yaz/Yasmin was safer than other types of oral contraceptives for human consumption and/or use and that Defendants' labeling, advertisements and promotions fully described all known risks of the product," Sims's suit states.

However, such representations were misleading, Sims claims.

In fact, from 2004 through 2008, Yaz has reportedly caused more than 50 deaths, which occurred in some women as young as 17, the complaint says.

"These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, and stroke in women in their child bearing years," the suit states.

The pill's danger possibly stems from Bayer's use of drospirenone, a new type of progestin only used in Yaz and its generic counterpart, Ocella, according to the complaint. The drospierenone causes increased levels of potassium in the blood, which can lead to a condition called hyperkalemia if potassium levels become too high, Sims claims.

In turn, hyperkalemia can cause heart rhythm disturbances, which can then cause the slowing of blood to the heart, allowing for the formation of blood clots. Those clots can lead to heart attacks or can break off and travel to the lungs, causing pulmonary embolism, which is the condition Sims suffered from. In another scenario, the blood clot can travel to the brain where it can cause a stroke, according to the complaint.

Click here for the rest of the article.

Originally posted at InjuryBoard by Paul Kiesel

Beware of Generic Birth Control Pill Ocella

Paul Kiesel — Mon, 17 Aug 2009 18:42:54 GMT

A 22-year-old woman who was taking Ocella, a generic version of the birth control pill Yasmin, recently suffered a stroke due to taking the drug. More information on this developing case will be available soon.

Since most women who take this drug tend to be on the younger side, it's difficult for many of them to ascertain if they're likely to fall prey to a stroke. It's important for anyone taking this drug, and for those who also choose to continue taking it, to make sure they let their doctors know of any changes in health, whether one considers the change small or significant.

If you or anyone you know has recently switched from Yasmin to Ocella or has just been prescribed Ocella, and you've experienced any type of side effects, contact the doctor who prescribed the drug to you and/or get in touch with an attorney, in order to protect your rights as a consumer.

For more information, contact Helen Zukin.

Originally posted at InjuryBoard by Paul Kiesel

Another Lawsuit Filed Against the Maker of "Yaz" Birth Control

Paul Kiesel — Thu, 05 Nov 2009 20:19:40 GMT

From ChicagoNow:

A woman is suing the maker of Yaz birth control after the contraceptive allegedly caused her to develop gall stones.

Melissa Johnson is suing Bayer, the maker of the prescription birth control, because she says it caused her to develop gall stones necessitating the removal of her gall bladder.

According to the complaint, Yaz contains drospirenone, a type of progestin not contained in any other birth control and of which "there is insufficient data to support its safe use." The complaint states that, since Yaz first appeared in the U.S., "hundreds of reports of injury and death" have been submitted to the FDA.

The lawsuit also points out the maker's "over-promotion" of Yaz that led to the FDA requiring it to run new TV ads correcting some of the misleading information.

Click here to view the complaint.

**Also, anyone who has been adversely affected due to taking these prescription drugs, like Yasmin, Yaz or Ocella, should get in touch with Helen Zukin. Ms. Zukin recently retained a client, a young woman, who unfortunately suffered from a stroke, after only taking Ocella (generic version of Yaz) for a month.

Originally posted at InjuryBoard by Paul Kiesel

Another Ethex and KV Pharma Drug Recall

Paul Kiesel — Mon, 02 Feb 2009 16:45:35 GMT

For the fifth time in just over 12 months, Ethex Corporation, a subsidiary of KV Pharmaceutical (drug manufacturer), issued another voluntary recall on several of their drug products, including various sized morphine sulfate tablets.

As noted previously in this blog, Ethex has had a serious problem with the consistency of its drug products' tablet size, as many of its prescription drugs, particularly morphine sulfate, have been manufactured twice the size than the product label suggests. This reoccurring problem can lead to drug dependency, myriad health problems, and even death.

Below is the drug recall information listed on Ethex Corp.'s website. Anyone in possession of these listed drugs and lot numbers should immediately consult a physician.

ETHEX Corporation Issues Nationwide Voluntary Recall of Products

St. Louis, Jan. 28, 2009 – ETHEX Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a nationwide voluntary recall of the products identified below (all lots within their expiration dates) at a wholesale or a retail level as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace.

Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to WHOLESALE Level:

Amlodipine Besylate Tablets, 10mg (58177-538-26 & 538-11)
Amlodipine Besylate Tablets, 2.5mg (58177-536-26)
Amlodipine Besylate Tablets, 5mg (58177-537-26, 537-07 & 537-11)
Benazepril HCl Tablets, 10mg (58177-342-04 & 342-08)
Benazepril HCl Tablets, 20mg (58177-343-04 & 343-08)
Benazepril HCl Tablets, 40mg, (58177-344-04 & 344-08)
Benazepril HCl Tablets, 5mg (58177-341-04)
Benzonatate Capsules, 100mg (58177-091-04 & 091-08)
Benzonatate Capsules, 200mg (58177-092-04 & 092-08)
Bromfenex ER Capsules (58177-019-04)
Bromfenex PD ER Capsules (58177-020-04)
Buspirone HCl Tablets, 10mg (58177-265-04 & 265-08)
Buspirone HCl Tablets, 15mg (58177-309-04 & 309-08)
Buspirone HCl Tablets, 5mg (58177-264-04 & 264-08)
Codeine Phosphate/Guaifenesin Tablets, 10mg (58177-223-04)
Dextroamphetamine Sulfate Tablets, 10mg (58177-312-04)
Dextroamphetamine Sulfate Tablets, 5mg (58177-311-04)
Dextroamphetamine Tablets, 10mg (58177-312-04)
Diltiazem HC1 Capsules, 120mg (58177-061-11)
Diltiazem HC1 Capsules, 120mg (58177-061-19 & 061-26)
Diltiazem HC1 Capsules, 180mg (58177-062-09 & 062-11)
Diltiazem HC1 Capsules, 180mg (58177-062-19 & 062-26)
Diltiazem HC1 Capsules, 240mg (58177-063-09 & 063-11)
Diltiazem HC1 Capsules, 240mg (58177-063-19 & 063-26)
Diltiazem HC1 Capsules, 300mg (58177-064-19 & 064-26)
Diltiazem HC1 Capsules, 360mg (58177-065-09 & 065-11)
Diltiazem HC1 Capsules, 360mg (58177-065-19 & 065-26)
Diltiazem HC1 Capsules, 420mg (58177-066-09 & 066-11)
Diltiazem HC1 Capsules, 420mg (58177-066-19 & 066-26)
Disopyramide Phosphate ER Capsules, 150mg (58177-002-04)
Doxazosin Mesylate Tablets, 1mg (58177-266-04 & 266-08)
Doxazosin Mesylate Tablets, 2mg (58177-267-04 & 267-08)
Doxazosin Mesylate Tablets, 4mg (58177-268-04 & 268-08)
Doxazosin Mesylate Tablets, 8mg (58177-269-04 & 269-08)
Ethedent Chewable Tablets, .25mg (58177-432-40)
Ethedent Chewable Tablets, .5mg (58177-433-40 & 433-09)
Ethedent Chewable Tablets, 1mg (58177-434-40 & 434-09)
EthexDerm BPW-10, 10% (58177-929-65)
EthexDerm BPW-5, 5% (58177-928-65)
Ethezyme 650 (58177-868-02)
Ethezyme 830 Papain-Urea (58177-816-02)
Ethezyme Papain-Urea (58177-804-02)
ETH-Oxydose Concentrated Solution (58177-914-04 & 914-56)
Guaifenex DM ER Tablets (58177-213-04)
Guaifenex GP ER Tablets (58177-373-04)
Guaifenex PSE 120 ER Tablets (58177-208-04)
Guaifenex PSE 60 ER Tablets (58177-214-04)
Guaifenex PSE 80 Tablets (58177-413-04)
Guaifenex PSE 85 Tablets (58177-478-04)
Hista-Vent DA Tablets (58177-227-04)
Hista-Vent PSE tablets (58177-426-04)
Histinex HC Liquid (58177-877-07 & 877-12)
Histinex PV Liquid (58177-883-07)
Hydrocodone Bitartrate & Acetaminophen Liquid (58177-909-07)
Hydrocodone Bitartrate/Guaifenesin Liquid (58177-881-07)
Hydrocortisone and Iodoquinol Cream, 1% (58177-803-02)
Hydroquinone 4% Cream w/SS, 1oz. (58177-802-02)
Hydroquinone 4% Cream, 1oz. (58177-801-02)
Hydro-Tussin CBX Liquid (58177-924-07)
Hydro-Tussin DHC Syrup (58177-926-07)
Hydro-Tussin DM Liquid (58177-906-07)
Hydro-Tussin EXP Liquid (58177-927-07)
HydroTussin HC Syrup (58177-915-07)
Hydro-Tussin Liquid (58177-890-07)
Hydro-Tussin XP Liquid (58177-916-07)
Hyoscyamine Orally Disintegrating Tablets, .125mg (58177-423-04)
Hyoscyamine Sublingual Tablets, .125mg (58177-255-04)
Hyoscyamine Sulfate ER Tablets, .375mg (58177-237-04)
Hyoscyamine Sulfate ER Capsules, .375mg (58177-017-04)
Hyoscyamine Sulfate Oral Tablets, .125mg (58177-274-04)
Isosorbide Mononitrate ER Tablets, 120mg (58177-201-04)
Isosorbide Mononitrate ER Tablets, 30mg (58177-222-04, 222-08 & 222-11)
Isosorbide Mononitrate ER Tablets, 60mg (58177-238-04, 238-08 & 238-11)
Meperidine/Promethazidne Capsules (58177-027-04)
Morphine InveAmp, 20mg x 1mL (58177-886-56)
Morphine InveAmp, 5mg/.25mL (58177-888-80)
Morphine Sulfate Concentrated Oral Solution 20mg/1ml (58177-886-01, 886-03 &886-05)
Morphine Sulfate Concentrated Oral Solution, 20mg/1ml (58177-886-57)
Morphine Sulfate ER Tablets, 100mg (58177-340-04)
Morphine Sulfate ER Tablets, 15mg (58177-310-04)
Morphine Sulfate ER Tablets, 200mg (58177-380-04)
Morphine Sulfate ER Tablets, 30mg (58177-320-04)
Morphine Sulfate ER Tablets, 60mg (58177-330-04)
Morphine Sulfate IR Tablets, 15mg (58177-313-04)
Morphine Sulfate IR Tablets, 30mg (58177-314-04)
NitroQuick Sublingual Tablets, .3mg (58177-323-04)
NitroQuick Sublingual Tablets, .4mg (58177-324-18 & 324-04)
NitroQuick Sublingual Tablets, .6mg (58177-325-04)
Nystatin Topical Powder, USP 15 grams (58177-839-45)
Nystatin Topical Powder, USP 30 grams (58177-839-46)
Nystatin Topical Powder, USP 60 grams (58177-839-61)
Ondansetron Orally Disintegrating Tablets, 4mg (58177-363-22)
Ondansetron Orally Disintegrating Tablets, 8mg (58177-364-22 & 364-56)
Oxycodone HCl Capsules, 5mg (58177-041-04 & 041-11)
Oxycodone HCl IR Tablets, 10mg (58177-461-04)
Oxycodone HCl IR Tablets, 15mg, (58177-445-04)
Oxycodone HCl IR Tablets, 20mg (58177-462-04)
Oxycodone HCl IR Tablets, 30mg (58177-446-04)
Oxycodone HCl IR Tablets, 5mg (58177-625-04 & 625-11)
Pangestyme CN 20 (58177-030-04)
Pangestyme CN10 (58177-029-04)
Pangestyme EC 100 (58177-031-04)
Pangestyme EC 250 (58177-031-06)
Pangestyme MT16 (58177-028-04)
Pangestyme UL12 (58177-048-04)
Pangestyme UL18 (58177-049-04)
Pangestyme UL20 (58177-050-04)
PhenaVent Capsules (58177-078-19)
PhenaVent D Tablets (58177-444-04)
PhenaVent LA Capsules (58177-095-19)
PhenaVent PED Capsules (58177-079-04)
Plaretase 800 (58177-416-04 & 416-08)
Potassium Chloride ER Capsules, 10mEq (58177-001-04, 001-08, 001-09, & 001-11)
Potassium Chloride ER Capsules, 8mEq (58177-677-04 & 677-08)
Potassium Chloride ER Tablets, 20mEq (58177-202-04, 202-08, 202-09 & 202-11)
Prednisolone Sodium Oral Solution (58177-932-05)
Prednisolone Syrup 15mg/5mL (58177-910-05 & 910-07)
Prednisolone Syrup 5mg/5mL (58177-912-03)
Propafenone HCl Tablets, 150mg (58177-331-04 & 331-11)
Propafenone HCl Tablets, 225mg (58177-332-04)
Propafenone HCl Tablets, 300mg (58177-333-04)
Pseudovent 400 Capsules (58177-096-04)
Pseudovent Capsules (58177-045-04)
Pseudovent PED Capsules (58177-046-04)
Tri-Vent DM Syrup (58177-925-07)
Tri-Vent DPC Liquid (58177-923-07)
Tri-Vent HC Liquid (58177-920-07)

Products Recalled to RETAIL PHARMACY Level:

Hydromorphone HCl Tablets, 2mg (58177-620-04 & 620-11)
Hydromorphone HCl Tablets, 4mg (58177-621-04 & 621-11)
Hydromorphone HCl Tablets, 8mg (58177-449-04)
Metoprolol Succinate ER Tablets, 50mg (58177-369-04, 369-09 & 369-11)
Metoprolol Succinate ER Tablets, 100mg (58177-368-04, 368-09 & 368-11)
Metoprolol Succinate ER Tablets, 25mg (58177-293-04, 293-09 & 293-11)
Metoprolol Succinate ER Tablets, 200mg (58177-358-04, 358-09 & 358-11)

Any wholesale or retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers (and to retailers for Hydromorphone HCl and Metoprolol Succinate only) nationwide who received any inventory of the recalled products with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their healthcare providers.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the company is unable to determine when distribution of these products will resume.

Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The recall announcement is posted on www.kvpharma.com.

Originally posted at InjuryBoard by Paul Kiesel

FDA Warning: List of Medical Devices & Diagnostic Products that May Contain Heparin

Paul Kiesel — Tue, 25 Nov 2008 16:16:27 GMT

Over the past year, Heparin, a widely used injectable anticoagulant, has come under intense scrutiny from consumer protection groups and the Food and Drug Administration.

In December 2007, the FDA recalled a shipment of heparin because of a growth of Serratia marcescens in several unopened syringes of this product. Serratia marcescens is a bacterium that can lead to life-threatening injuries and/or death.

Only six months ago, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. The FDA released a statement that revealed the contaminated heparin killed at least 81 people in the U.S.

The most high-profile instance of negligent heparin overdose occurred in November 2007, when actor Dennis Quaid's twelve-day-old twins were accidentally given an adult dosage of the drug (the adult dosage was 1,000 times the recommended dosage for infants). The Quaid family subsequently sued the manufacturer of the product, Baxter Healthcare Corp., for over $50,000, due to confusing labeling and design that made the adult and infant versions of the product difficult to differentiate.

And, just this past summer, in July, another set of twins born at a Texas hospital died after an accidentally administered overdose of the drug.

Thus, the FDA updated its heparin recall list to include medical devices and diagnostic products that may contain or be coated with heparin. The FDA does not mean to suggest that all of the products herein have been or are affected by contaminated heparin, but its purpose is to warn consumers of potential products and devices that could be life-threatening if they contain contaminated heparin.

Also, as several other cases arose of people falling ill or dying due to products that contained or were coated with contaminated heparin (i.e another instance that involved Baxter International and one of its suppliers, a company that spun off from Oscar Meyer; the connection: pigs naturally produce proteins used in pharmaceuticals.), the FDA felt it was necessary to include companies that have otherwise yet to receive a complaint or have been forced to recall their products, due to the diversity in suppliers of heparin and its widespread usage.

Below is the FDA list warning consumers to be cogent of the products being administered to them and/or used. If any one has used one or more of these products over the past year and (s)he is concerned with short- or long-term affects, contact Mr. Paul R. Kiesel or Ms. Helen Zukin at (310) 854-4444.

FDA HEPARIN PRODUCT WARNING LIST:

Manufacturer or Distributor	Product
3M Health Care	3M CDI Quick-Cells with Heparin Treatment
	3M Sarns Flow Sensor , Centrifugal Control Module
	Sarns Arterial Cannulae with Duraflo Treatment
	Sarns Venous Return Catheters with Duraflo Treatment
A-Med Systems, Inc.	Heparin Coated Miniature Centrifugal Bypass Pump
AMO Groningen BV	CEEON Heparin Surface Modified UV Light-Absorbing Posterior Chamber IOLs
AMO Groningen BV	CEEON Heparin Surface Modified UV Light-Absorbing Anterior Chamber IOLs
Akers Labs	[Platelet Factor 4 RIA]
Alsius	Coolgard and catheter thermal regulation system
	Thermogard System
	ICY Catheter Models IC3583 and IC3893
	Quattro Catheter IC4593
	Fortius Catheter
AM2 PAT Inc.	Sierra Heparin Flushes
American Bentley	Heparin Coated Arterial Blood Filters
American Bentley	Heparin Coated Extracorporeal Circuits
American Edwards Laboratories	Heparin Coated Catheter
American Edwards Laboratories	Swan-Ganz Heparin Coated Catheter
American Bioproducts	[Ptt-Lt]
American Bioproducts	[Stachrom Heparin]
American Dade	[Lithium Heparinized Blood Collect-Tube]
American Dade	[Actin Fs APTT]
American Diagnostica	[Actichrome Heparin]
Amsino Medical USA	Heparin Flushes
APP	Heparin Flushes
Argon Medical Corporation	Heparin Coated Stainless Steel and Teflon Heparin-Coated Guidewires
Argon Medical Corporation	Heparin Coated Thermodilution Catheters
Arrow International, Inc.	Arrow-Howes large bore multi-lumen central venous catheter
Arrow International, Inc.	HANDS-OFF Heparin Coated Thermodilution Catheters
Artefactos De Vidrio S.A. De C.V.	[Ven-O-Vac Blood Collection Vacuum Tubes]
Atrium Medical	Atrium Heparin Coated Catheters
Avecor Cardiovascular Inc.	Affinity Hollow Fiber Oxgenator with Trillium Biopassive Surface
Avitro LLC	Heparin Flushes
B. Braun of America	H.E.L.P System
B. Braun of America	Heparin Flushes
Baxter Bentley Laboratories	Duraflo II Heparin Treated Suction Wands
Baxter Bentley Laboratories	Duraflo II Heparin Treated Femoral Cannulae
Baxter Edwards	Carpenter-Edwards Classic Ring with Duraflo Treatement
Baxter Healthcare Corp.	Hep-LOCK Heparin Flushes
Becton Dickson	B-D Heparinized Longdwel IV Catheter
	Heparin Coated Thermodilution Catheter
	Heparin Coated Luminal Pacing Catheter
	Heparin Flushes
	[Vacutainer Brand Plus Sodium Heparin Tube]
	[Bd Vacutainer Plus Pst Ii Tube]
	[Vacutainer Brand Blood Collection Syringe]
Bio/Data Corp	[Cephalinex APTT]
Biosensors Intl PTE, LLC	Heparin Coated Thermodilution Catheters
Biotrack, Inc	Biotrack APTT
Boston Scientific Corp	Constellation Multiple Electrode Pacing and Recording System
Cardiac Assist, Inc.	TandemHeart Transseptal Cannula Set-EF
Cardiovascular Diagnostic Services	[Aoag-1 APTT Test Card]
Cardiovascular Diagnostics	[(Tas) Low Range Heparin]
Careside Hemotology	[APTT]
Celsus	Heparin Flushes
Ciba Corning Diagnostics Corp.	[Ciba Corning Blood Collection Capillary Tube]
Coaxia Inc	Coaxia Neuroflo Catheter
COBE Laboratories	Heparinized Arterial Screen Blood Filter
	Sentry Smarxt 43 Micron Arterial Filter
	Smarxt BMR 1900 Closed Venous Reservoir Bag
	Smarxt VVR 4000 Filtered Hardshell Venous Reservoir
	Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir
	Smarxt HVR 4000 Surface Modified Hardshell Venous Reservoir
	Closed Venous Reservior Bags with Smarxt
	Sorin Biomedica Smarxt BCD Vanguard Surface Modified Blood Cardioplegia System
	Smarxt Optimin Surface Modified Hollow Fiber Membrane Oxygenator
	Smarxt Optima XP Surface Modified Hollow Fiber Membrane Oxygenator
	CML Duo with Smarxt Surface Modified Membrane Oxygenator
	Smarxt Tubing and Connectors
Cook, Inc	Amplatz Heparin Coated Catheter
Cordis	BX Velocity with Hepacoat Coronary Stent
Covidien	Heparin Flush Solutions
	Palindrome Emerald 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating
	14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire)
Critikon Company, LLC	Heparin-Coated Balloon Thermodilution Catheters
Current Technologies Inc.	[Arterial Micro Collection Kit]
Current Technologies Inc.	[Prefilled Arterial Blood Sampling Syring]
Dade Behring, Inc.	Dimension Vista System Drugs of Abuse Calibrator
Dade, Baxter Travenol	[Heparin Assay]
Daig Corp	Heparin Bonding for Cathteters
Datascope Corp	Percluder-DL Occluding Balloon Heparin Coated
Diagnostica-Stago	[Rotachrom Heparin]
Dupont Medical Products	[Dupont Apc Blood Collection Container With Lithiu]
Edwards Lifesciences	Embol-X Intra-Aortic Filter
	Heparin Coated Arterial Blood Filters
	Retrograde Cardioplegia Cannula with Duraflo
	PediaSat Oligon Oximetry Catheters with AMC Thromboshield Heparin Coating
	PreSep Oligon Oximetry Catheters with AMC Thromboshield Heparin Coating
	Polyethylene Central Venous Catheter with Heparin Coating
	Swan-Ganz and Edwards Laboratories Heparin Coated Catheters
	Edwards Vantex Central Venous Catherer with Thromboshield Coating
	Edwards AVA 3Xi Device with Thromboshield Coating
	Edwards AVA High-Flow Device with Thromboshield Coating
	Edwards IntroFlex Percutaneous Sheath Introducer with Thromboshield Coating
	Venous Reservoir Bag Model No. BMR-800 with Heparin
	Venous Reservoir /Cardiotomy Autotransfusion Filter
	Duraflo II Heparin Oxygenator Model Univox Gold
	Univox Gold Membrane Oxygenator with Duraflo
	Extracorporeal Circuit with Duraflo II Heparin Treatment
	Sarns Centrifugal Pump with Duraflo II Treatment
	Jackson-Pratt Gold Wound Drains with Duraflo II
	Bentley Quick-Prime Hemoconcentrator with Duraflo Treatment
Electro-Catheter Corp	Elecath Heparin-Coated Catheters
	Elecath Heparin-Coated Temporary Pacing Catheters
	Elecath Heparin-Coated Thermal Dilution Catheters
Em Diagnostics	[Easy-Test PTT]
Embol-X, Inc.	Embol-X Aortic Filters
	Aortic Cannula Metal J-Tip (24 Fr)
	Embol-X Aortic Occlusion and Carioplegia Cannula
	Embol-X Introducer Model CF00200
Emisphere Technologies, Inc	Heparin Flushes
EV3	Spiderfx Embolic Protection Device
Excelsior Medical	Heparin Flushes
GISH Biomedical, Inc.	GISH Tubing and Connectors with GBS Coating
	GISH Arterial Filter with GBS Coating
	GISH ATR2900 and CAP35 Series Reservoirs with GBS Coating
	V-Bag with GBS Coating
	GISH CAPVRF44 Hardshell Venous Reservoir Ba with GBS Coating
	Soft Venous Reservoir (SVRXX) with GBS Coating
	IBC Flopump with GBS Coating
	Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with GBS Coating
Gould, Inc.	Heparin Coated Thermodilution Catheters
Greiner Bio-One	[Greiner Vacuette Blood Collection Tube W/Lithium]
Greiner Bio-One	[Vacuette Evacuated Blood Collection Tubes]
Greiner Meditech Inc.	[Greiner Minicollect Li Heparin Gel]
Greiner Meditech Inc.	[Greiner Minicollect Lithium Heparin Gel Blood Col]
Guidant Corp	Neurolink System
Helena Laboratories	[Chrom Z-Heparin]
Helena Laboratories	[APTT-ES]
Hospira, Inc.	Opticath Central Venous Oximtery Probes
	Latex-free Advanced Sensor Catheters
	Flow-Directed Heparin Coated Thermodilution Catheter
	Opticath Catheter
	Opticath Heparin Coated Flow Directed Catheter
	Oximetrix Flow Directed Thermal Dilution Catheter
Hyphen Biomed	[Biophen Heparin 3,6]
Infusaid Corp	Heparin Lock Maintenance Kit
Innerdyne, Inc.	Innerdyne Radially Expanding Vascular Access System
Instrumentation Laboratory Co	Heparinized Flow Directed Thermal Dilution Catheter
	[Il Test]
	[Coamatic Heparin]
International Technidyne (ITC)	[Hemochron Jr]
International Technidyne (ITC)	[Hemochron Kaolin-Activated Heparin]
Intervascular, Inc.	Intergard Knitted Collagen Coated and Heparin Bonded Vascular Protheses
Intervascular, Inc.	Intergard Knitted Ultra-Thin Collagen Coated and Heparin Bonded Vascular Protheses
J-Lloyd Medical, Inc.	Flow Direct Thermodilution Balloon Catheter with Heparin Coating
Johnson & Johnson	Arterial 20/40 Micron Filters with Heparin Coating
KMA Inc.	Heparin Coated Thermodilution Catheter
Maquet Cardiopulmonary AG	Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating
Mansfield Scientific	Heparin Coated Temporary Pacing Electrode
Martech Medical Products Inc.	[Marksman Arterial Blood Gas Syringe]
Medefil, Inc.	Heparin Flushes
Medelec Intl. Corp.	[Blood Specimen Collection Devices]
Medical Components, Inc	MedComp DUO-COAT Catheter Double Lumen
Medrad, Inc.	Benzalkonium-Heparin Coated Guidewires
Medtronic	Trillium Bio Disposable Blood Flow Probe
	Trillium Tri-Optic Measurement Cell
	Trillium Affinity NT Cardiotomy Venous Reservoir
	Trillium Biopump Plus Model BPX80T
	Affinity 20 Micron Arterial Filter with Trillium Biosurface
	Affinity 38 Micron Arterial Filter with Trillium Biosurface
	Select 3D (and CAP) Arterial Cannula with Carmeda Boactive Surface
	Affinity Pediatric Arterial Filter
	Affinity NT Hollow Fiber Oxygenator
	Trillium Myotherm XP Cardioplegia Delivery System
	Tubing and Connectors with Trillium Biopassive Surface
	Carmeda or Trillium Coated Myotherm Blood Cardioplegia System
	Carmeda Coated Intersept Pediatric Arterial Filter
	Minimax/Maxima Hollow Fiber Oxygenators
	Minimax Oxygenation System
Mentor Corp	Mentor Tissue Expanders with TDMAC Coating
Microbio-Medics Inc.	[Microtek Medical`S Blood Collection Kit]
Millenia Healthcare, Corp.	Heparin Flushes
Morris innovative Research, Inc.	Femoral Introducer Sheath and Hemostasis (FISH) Device 5, 6, and 8 French
Nova Medical Speicialties	Heparin Coated Balloon Thermodilution Catheters
Novalung GMBH	Novalung Surgical Lung Assist (SLA) Membrane Lung
Organon Teknika	[MDA Heparin Anti-X]
Ortho	[Synthafax]
Oximetrix Inc.	Opticath Heparin Coated Flow Direct Catheter
Pacific Hemostasis	[Thromboscreen APTT]
Parke-Davis Co.	Deseret Heparin Coated Flow Catheters
Parker Pharmaceutical, Inc.	Heparin Flushes
Physician Industries, Inc.	PICC Insertion Tray with Hep-LOCK Heparin Flush
Precision Biologicals	[APTT Reagent]
Radiant Medical	Radiant Medical Endocatheter Temperature Probe
	Setpoint Endovascular Temperature Management System
	Reprieve Endovascular Termperature Therapy System
Radiometer Medical Aps	[Safepico]
Ram Scientific	[Safe-T-Fill Capillary Blood Collection System]
Research Industries Corp.	Duraflo II Heparin Treated Cannulae
Research Medical. Inc.	TDMAC-Heparin Coated RMI Carotid Bypass Shunt
Rocap/Sabratek Corp	Heparin Flushes
Roche Diagnostics	[Coaguchek]
Safety Diagnostics Inc.	[Pinset]
Shapes	Heparin Flushes
Shelhigh, Inc	Delcol Heparinized Pericardial Substitute
Sherwood Medical Co.	Argyle Griffith TDMAC Heparinized Veno-venous Shunt
	Heparinized Wound Suction Tubing
	Heparinized Saratoga Sump Drain
	Heparinized Penrose Tubing
	Heparinized Intravenous Cannula
	[Lancer Coagent APTT]
	[Monoject Sample Capillary Plasma Sep W/Lith Hepar]
	[Monoject Samplette Capillary Blood Coll]
	[Monojet Sps Blood Collection Tube]
Sigma	[APTT Reagent]
Sims Portex Inc.	[Pro-Vent Pulsator Arterial Blood Sampling Syring]
Smith's Healthcare Manufacturing	Injection Adaptor Heparin Lock
Smiths Industries Medical Systems Inc.	[Sims Pro-Vent 250 (500) Plus Arterial Blood Sample]
Smith's Medical ASD	Injection Adaptor Heparin Lock
Solo Pak Labs	Heparin Flushes
Sorenson Research	Flow-Directed Heparin Coated Thermodilution Catheter
Spectramed, Inc.	Heparin Coated Luminal Pacing Catheter
Spire Biomedical, Inc.	15.5 Fr Decathalon Coated Catheters
Starplex Scientific Inc.	[Vacuplus Tubes With Green Stoppers]
Statspin Technologies	[Statspin Statsampler]
Sunscope Intl, Inc.	Heparin Coated Thermodilution Catheter and Accessories
Terumo Corp.	[Capiject Sys Capillary Blood Collect]
Terumo Corp.	[Venoject Ii Blood Collection Tubes]
Vital Scientific	[APTT]
Vital Signs, Inc	Heparin Flushes
W.L. Gore & Associates, Inc.	Gore Propaten Vascular Graft
W.L. Gore & Associates, Inc.	Gore Viabahn Endoprosthesis with Heparin Bioactive Surface
Wako Intl. Inc.	[Seri-Sep Serum/Plasma Islolator]

Originally posted at InjuryBoard by Paul Kiesel

Associated Press: KV Pharmaceutical and Ethex Recall Morphine Sulfate Tablets and 17 Other Generic Products Due to Potential Life Threatening Consequences from Oversized Tablets

Paul Kiesel — Tue, 18 Nov 2008 21:03:56 GMT

On Friday, November 7, 2008, the Associated Press reported that Ethex Corporation, a manufacturer of the pain medication Morphine Sulfate, is voluntarily recalling five of their generic drug brands due to reports of tablets being as much as twice the size and potency as the labeled active ingredient levels suggests.

Morphine Sulfate is one of the five generic drugs that Ethex is recalling. However, this is not the first recall that's been issued on Ethex Corp.'s Morphine Sulfate drug this year.

On June 10, 2008 the FDA issued a MedWacth E-mail Alert on Ethex Corp.'s "Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot to a Report of a Tablet with Twice the Appropriate Thickness." The FDA warned then that any consumers that begin or continue to take this drug are at the risk of morphine overdose which could lead to breathing problems, erratic behavior, seizures, low blood pressure, nausea, vomiting and even death.

A few days after the FDA issued its MedWatch Alert, Ethex expanded its morphine pill recall to include specific lots of morphine sulfate 60 mg extended release tablets and of 30 mg tablets. These recalled lots were distributed between June 2006 and May 2008.

On October 15, 2008, Ethex released a voluntary recall to the consumer level of three specific lots of dextroamphetamine sulfate 5mg tablets, due to the presence of oversized tablets being reported by two pharmacists. A second recall on Morphine Sulfate was issued three weeks later and Ethex expanded this recall effort to include Propafenone HCI, Isosorbide Mononitrate and Dextroamphetamine Sulfate, which are all manufactured under the brand name "ETHEX."

The Morphine Sulfate tablets that have been recalled have labeled potency levels of 15mg, 30 mg, and 60 mg tablets (see below for specific lots).

In all, over 18 generic and non-branded products have been recalled in 2008 by Ethex and/or its parent company KV Pharmaceutical.

No report of any oversized tablets from any of the lots of the products involved in these June, October and November recalls has been received by ETHEX from any wholesaler, retailer, consumer or caregiver.

We are in the process of compiling all of the lot numbers and product descriptions for all 18 drugs that have been recalled from June through November 2008.

Below is a list of the lots involved in the recall that were shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010

Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011

Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011

Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “331” with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “332” with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “333” with a bisect on the reverse.

The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed “E” bisecting “30” on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed “E” bisect “60” on one side and bisect on the other side.

The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with “15” on one side and an “E” on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a “15” on one side and an “ETH” on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with “30” on one side and an “ETHEX” on the reverse.

The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge, orange mottled tablet debossed “ETHEX” and “312” on one side and double-scored on the other side.

Originally posted at InjuryBoard by Paul Kiesel

Walgreens Sends Urgent Drug Recall Information Letter Out to Ethex Morphine Sulfate Prescription Customers

Paul Kiesel — Fri, 09 Jan 2009 21:34:04 GMT

Ethex Corporation has been recalling (four times in the past year to be exact) several of its prescription drug products, due to some of the tablets being oversized (upwards of twice the appropriate level of the active ingredient).

Below is the content of Walgreens' recall letter per Ethex's Morphine Sulfate oversized tablets:

The manufacturer of Morphine Sulfate IR tables, Ethex Corp., is recalling several lots of this medication because there is the possibility that some tablets may be oversized and may contain more than the appropriate level of active ingredient. Your prescription may have included product from one of these affected lots.

We do not recommend that you discontinue taking Morphine Sulfate IR tablets without speaking to your physician. We ask that you attempt to contact your physician or other health care provider and share this information with them. You may return any remaining Morphine Sulfate tablets to your local Walgreens pharmacy for a refund. If you have any questions about this recall, you may contact the manufacturer at 1-800-748-1772 from Monday through Friday 8 a.m. to 5 p.m. C.S.T or via e-mail at customer-service@ethex.com.

*Also, anyone who wants to learn more about Ethex's recalls over the past 90 days can click here and browse several blogs that have further information.

Originally posted at InjuryBoard by Paul Kiesel

Rite Aid Warning Customers About Ethex Drug Recall

Paul Kiesel — Thu, 20 Nov 2008 15:35:00 GMT

Rite Aid customers should be receiving a letter this week, informing them that a major drug manufacturer, Ethex (a subsidiary of KV Pharmaceutical), has issued a recall of several of its generic products, including Morphine Sulfate.

Ethex sent out oversized tablets -- some double the expected dosage -- of over 10 of its prescription medicine. The recall includes a stimulant, morphine (Morphine Sulfate) and couple of Ethex heart medication products.

In Boise, Idaho, some customers have already received the letter from Rite Aid warning them to cease taking these prescriptions and to return the product to a Rite Aid pharmacy. Mark Phillips, an assistant pharmacy director at Boise's Saint Alphonsus, said that taking a double-dose of any of the recalled products can lead to serious effects, even death.

KBCI, a local Boise news station, reported that a Rite Aid spokeswoman said the company has pulled all the affected prescriptions from their shelves. They have also sent a letter to everyone who has filled a prescription for the drugs in the last 12 months, even if they may not be affected by the recall.

Below is the press release sent out by Ethex on November 7, 2008. Anyone who has taken Ethex's Morphine Sulfate or other drugs affected by the recall and would like to know what their options and rights are as a consumer should get in touch with Mr. Paul R. Kiesel or Ms. Helen Zukin at 310-854-4444:

ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic/non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.

Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.

The lots involved in the recall were all shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010

Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011

Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011

Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "331" with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "332" with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "333" with a bisect on the reverse.

The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed "E" bisecting "30" on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed "E" bisect "60" on one side and bisect on the other side.

The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with "15" on one side and an "E" on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a "15" on one side and an "ETH" on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with "30" on one side and an "ETHEX" on the reverse.

The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge, orange mottled tablet debossed "ETHEX" and "312" on one side and double-scored on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers who have received any inventory of the recalled product lots with instructions for returning the recalled products. The notification also includes instructions for the retailers/pharmacies to contact consumers who were dispensed these drugs for replacement of the product and/or refund. If the wholesalers and retailers have not already done so, they are urged to contact the number below regarding procedures for returning the recalled products. If consumers have any questions about the recall, they should call the number listed below for customer inquiries, their physician, their pharmacist or other health care provider.

Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8:00 am to 5:00 pm Central Standard Time (CST).

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Originally posted at InjuryBoard by Paul Kiesel

Odor Reports Prompt Tylenol Recall

Chrissie Cole — Wed, 29 Jun 2011 10:37:00 GMT

Odor reports have prompted the voluntary recall of one lot of TYLENOL, Extra Strength Caplets in the U.S. The affected products were manufactured in February 2009.

McNeil is taking this measure following reports of odor reports including moldy, musty odor which has been linked to a trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).

TBA has been associated with temporary and non-serious gastrointestinal symptoms.

The recall involves the following lot of Tylenol:

TYLENOL, Extra Strength Caplets, 225 Count – Lot # ABA619 – UPC Code: 300450444271

Consumers are urged to discontinue use of this product if it is subject to the recall. Contact McNeil by visiting www.tylenol.com or by calling 1-888-222-6036 for information about a refund or product coupon.

Medical questions and concerns should be directed to your medical doctor. To report adverse reactions, use the FDA’s MedWatch program online or by mail.

Originally posted at InjuryBoard by Chrissie Cole

FDA: Peanut Butter's Long Shelf Life a Problem

Paul Kiesel — Mon, 09 Feb 2009 18:58:04 GMT

The FDA is concerned that the "Peanut Butter Problem" stemming from the unsanitary conditions at Peanut Corp. of America will continue for a while.

"I expect this outbreak to go on for a long time [because the foods with peanut butter in them have long shelf lives]," said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest in Washington.

Even peanut butter products purchased in early 2007 could be tainted with the salmonella bacteria, which is what the FDA cites as the reason for the current recall and the shutdown of the Georgia-based peanut plant. Peanut Butter products from the plant have accounted for eight deaths and 575 illnesses in 43 states.

The FDA has advised anyone with peanut butter products to check the FDA website's peanut butter recall page to make sure the product in possession doesn't have peanut butter that originated from the Georgia plant.

Below is an article from the Los Angeles Times discussing how Peanut Corp. lied to the FDA about its Salmonella testing:

From the L.A. Times:

Peanut Corp. of America, the company that produced the contaminated peanut butter now being widely recalled, lied to Food and Drug Administration investigators about shipping batches of the food known to be tainted with salmonella bacteria, the agency said Friday.

The company had previously told the FDA that some lots of peanut butter had initially tested positive for the bacterium, then were retested and found to be negative before they were shipped. But further investigation showed that the company actually shipped some of the lots before the second tests were completed. Other lots were shipped without testing and, in some cases, no second test was performed even after the first one came back positive. The lots were shipped to a vast array of food manufacturers and found their way into such items as cookies, crackers, health bars, ice cream and dog biscuits. Peanuts and peanut products from a Peanut Corp. plant in Georgia have now been linked to eight deaths and 575 illnesses in 43 states. In January, food companies began what has become an unprecedented nationwide recall of hundreds of snacks and other foods containing the products.

"I expect this outbreak to go on for a long time," in part because the foods have a long shelf life, said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest in Washington.

The FDA did not formally announce the new findings about the company's testing, but rather made small revisions Thursday to an online report about the investigation. Only when a Washington Post reporter discovered the changes did the news become more widely known.

As part of the investigation, the FDA found that 12 contaminated lots from the small Blakely, Ga., plant were shipped to schools in California, Minnesota and Iowa from January 2007 to November 2007.

Also, 32 truckloads were shipped to the U.S. Department of Agriculture, which had been inspecting the plant, for its school lunch programs.

Susan Acker, a spokeswoman for the USDA, said she did not know of any illnesses linked to the lots shipped to the agency.

Even so, some observers said, the fact that the lots were shipped at all is indicative of reckless business practices [. . .] For the rest of the article, click here.

Originally posted at InjuryBoard by Paul Kiesel