Los Angeles Personal Injury Lawyer - morphine sulfate

Ethex Expands Recent Recall Even Further

Paul Kiesel — Thu, 05 Feb 2009 20:37:09 GMT

From Forbes:

Associated Press - KV Pharmaceutical Co. is issuing its fourth product recall in about three months because some of its prescription prenatal and iron supplements were made under unsatisfactory conditions.

Late Tuesday, KV said it is voluntarily pulling dozens of prescription iron supplements and prenatal vitamin capsules and tablets because the products were made under conditions that didn't comply with industry standards. The recall includes products made by its Ther-Rx and Ethex divisions.

The company also extended a recall of five drugs made by Ethex, KV's generic business. Those drugs, along with dozens of others, were recalled last week at the wholesale level because of manufacturing problems. The new recall extends to the retail level.

In afternoon trading, KV shares lost 10 cents, or 13.9 percent, to 62 cents.

KV has issued four spates of product recalls since Nov. 7, citing manufacturing problems and accidentally oversized pills. On Jan. 26, the company recalled most of its products, and stopped its manufacturing and shipping operations. It warned that the Food and Drug Administration might choose to investigate or file charges.

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

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

KV Pharmaceutical and Ethex Corporation: We've Got an Oversized Pill Problem

Paul Kiesel — Wed, 07 Jan 2009 21:53:01 GMT

Two days before Christmas, KV Pharmaceutical Co. lost half its value in New York trading after the drugmaker, announcing a fourth recall of medicines that may contain excess doses, stopped shipping prescription tablets, according to Bloomberg News.

When asked how many pills were affected or how many lots had improperly sized tablets of medicine, David Van Vliet, KV's interim CEO, said, "We’re not sure that there are any problems with these products."

Hmm...?

If there isn't anything wrong with what KV and its subsidiary company Ethex were shipping out to the public, then why would the company risk further economic damage, and take a large material hit to its operating procedures, as it did on November 13 when the company was unable to file its Q3 earnings because of an October and November drug recall (oversized morphine sulfate tablets)? Because the two companies are cogent that some, maybe not all, of the drugs that were being shipped out were, once again, oversized. And because the last thing a company like KV needs is someone to ingest a double dosage of morphine sulfate (which can result in death or at the least drug dependency) or one of its other 17 drugs that have been affected by recalls this past year.

For the acting CEO of KV to hastily halt shipments, based on a hunch, seems ridiculous. Mr. Van Vliet has to be aware that there are fundamental problems at KV and Ethex (especially when it comes to quality control), because this was the fourth time in 2008 the company had to suspend large shipments of its drugs, due to carelessness of the tablets being oversized.

Originally posted at InjuryBoard by Paul Kiesel

Morphine Overdose Killed Army Soldier

Paul Kiesel — Thu, 04 Dec 2008 20:30:06 GMT

Earlier this year, a Fort Huachuca soldier died of a morphine overdose at the Army base's medical barracks, an investigation concluded this week, and authoritites are trying to determine who provided the drug, according to the Associated Press.

Pfc. Eli Baker, 22, had just finished boot camp and was still in the process of training at the Central Arizona Army base when he was found dead on January 28 in Fort Huachuca's Warrior Transition Unit.

The unit provides medical and mental-health support for soldiers wounded in action or for troops recovering from other medical conditions.

Chris Gray, a spokesman for the U.S. Army Criminal Investigation Command, said," We have reason to believe that someone supplied him with that morphine, but he was not prescribed that morphine."

That statement issued by the Army must be disappointing to the family of Eli Baker, as 1. It'd be immediately obvious, particularly in the military, to find out whether Mr. Baker had been prescribed morphine (and it took them 11 months to figure this out?) and 2. Unless Mr. Baker had been prescribed the morphine, naturally, someone would have had to given it to him.

The most interesting aspect of the Army's investigation into what is ostensibly a case of negligent homicide, is what they've omitted. They have not suggested or disclosed that the morphine table came from the Warrior Transition Unit. And they have not connected the morphine overdose to the FDA's three recalls on Ethex Morphine Sulfate tablets, which occurred four months after Mr. Baker's death. (*Two of the recalls were voluntarily made by Ethex, after the FDA issued the first; the FDA then issued, simultaneously, two more recalls on 17 other Ethex generic products.)

The FDA doesn't typically mandate a recall on a product unless the agency is fearful of life-threatening consequences, and the FDA has yet to receive any of the recalled lots of Ethex Morphine Sulfate. Does this mean that Mr. Baker's death was the result of an oversized tablet? No, but unless the Army investigates the Warrior Transition Unit's stock of medication (and who may have been prescribed morphine at the Army base upon or before Mr. Baker's arrival), and examine whether or not the facility was stocked with any Ethex products, Eli Baker's family will lack the closure it deserves and this case will likely go unsolved.

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

President Bush, Wyeth v. Levine & Ethex's Morphine Sulfate: Consumers Beware!

Paul Kiesel — Wed, 19 Nov 2008 18:15:07 GMT

As President Bush does his best to rewrite federal rules aimed at pre-empting product liability litigation (50 rules that would govern product-liability laws from motorcycle brakes to pain medicine, like Ethex's Morphine Sulfate that was recalled by the FDA twice this year), which would block product-safety lawsuits by consumers and states, a Supreme Court case is being heard, Wyeth v. Levine, that could tip the scale in favor of "big-business" (Bush) or consumer protection laws (us).

If the Supreme Court rules in favor of Wyeth, the defendant and manufacturer of a drug that caused the plaintiff, musician Diana Levine, to lose her right arm, Bush will be able to manipulate the language of these federal rules, aimed at state preemption laws, to make sure they stick around long after he's left the White House. If it the Court rules in favor of Levine, which is probable since she was already awarded $6 million from the physician whose decision of how Wyeth's drug was to be administered (IV push instead of IV drip method) caused Levine to develop gangrene and, subsequently, left her without a right arm, it's doubtful that Bush's new regulations will have a lasting impact past a year or two.

On top of this, Ethex, a subsidiary of KV Pharmaceutical, has recalled its generic drug Morphine Sulfate due to oversized tablets that can pose life-threatening consequences. If Bush's laws go into effect next month or before January 20, 2009, and someone were to fall gravely ill or even die due to ingesting the drug (which the person probably thought was either a 15 mg, 30 mg or 60 mg tablet, when in fact it could have been as much as double the labeled level of active Morphine Sulfate), what can that person do to find a proper legal remedy? They will find it all the more difficult to pursue legal recourse due to Bush's wanton need to have his corporate buddies approve of him.

Former Bush domestic-policy adviser Jay Lefkowitz, whose been an instrumental force in these processes of taking away consumer rights, said that the president's philosophy is, "You can't ask companies to follow different standards." Because they're not smart enough?!

Lefkowitz's logic: The Bush Administration believes that corporations are too simple minded to follow both federal and state laws, particularly when it comes to consumer products or protection, therefore, consumers are now fortunate enough to have the burden of protecting themselves against drugs, like Ethex's Morphine Sulfate, be placed on them.

Now, how could any person who's been prescribed Ethex Morphine Sulfate know the difference between an actual 60 mg tablet (size) and one that is oversized (essentially 120 mg-sized), unless Ethex made a 120 mg tablet (which it does not) and had the latter-sized table right next to him or her. Consumers trust that the FDA will impose regulations on drug manufacturers, that physicians will follow how drugs are to be administered or prescribed, and if manufacturers and physicians fail to follow these FDA rules, a consumer can and should be able to seek the appropriate legal recourse for the distresses (physical and emotional) he or she suffered.

If only January 20, 2009 were tomorrow...

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