Yourlawyer.com (Ethex Morphine News)

ETHEX Generic Drug Recall Expanded

Thu, 05 Feb 2009 00:00:00 -0800

ETHEX Corp. has expanded an earlier generic drug recall. Like other ETHEX recalls from the past several months, this expanded drug recalls was necessary because of manufacturing problems at KV Pharmaceuticals, the parent company of ETHEX.

The expanded recall includes:

Morphine Sulfate Extended-Release Tablets 15mg, 30mg & 60mg (All Strengths)
Morphine Sulfate Immediate-Release Tablets 15mg & 30 mg (All Strengths)
Dextroamphetamine Sulfate Tablets 5mg & 10mg (All Strengths)
Isosorbide Mononitrate Extended-Release Tablets 30mg, 60mg & 120mg (All Strengths)
Propafenone HCl Tablets 150mg, 225mg & 300 mg (All Strengths)

The recall of these drugs had previously been issued at the wholesale level, but is now being expanded to the retail level. ETHEX is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with the Food & Drug Administration's current Good Manufacturing Practice (cGMP) regulations.

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications 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.

Any 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.

Last month, KV Pharmaceuticals suspended manufacturing and shipping of all of its products, including those made under the ETHEX name. That announcement followed an inspection that began in December by the FDA of the company’s operations and inventory. Because of the manufacturing problems cited by the FDA, ETHEX has issued several recalls in the past year. Earlier this week, ETHEX issued a recall of its prescription infant vitamins and prescription iron supplements. Just last week, the problems at KV Pharmaceuticals prompted ETHEX to recall scores of generic drugs that might be defective.

In December, the drug maker recalled a single lot of Hydromorphone HCl 2 mg tablets because some of them may have been oversized. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. Those medications included various lots and sizes of Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets and Dextroamphetamine Sulfate Tablets. That action followed an October recall of three lots of potentially oversized Dextroamphetamine Sulfate. And in June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.

ETHEX Recalls Infant Vitamins, Iron Supplements

Wed, 04 Feb 2009 00:00:00 -0800

ETHEX Corp. has issued another big drug recall. This time ETHEX, a unit of KV Pharmaceuticals, is recalling several varieties of prescription infant vitamins and prescription iron supplement products that may have been manufactured under conditions that did not sufficiently comply with the Food & Drug Administration's (FDA) current Good Manufacturing Practice (cGMP).

Last month, KV Pharmaceuticals suspended manufacturing and shipping of all of its products, including those made under the ETHEX name. That announcement followed an inspection that began in December by the FDA of the company’s operations and inventory. Because of the manufacturing problems cited by the FDA, ETHEX has issued several recalls in the past year.

This latest ETHEX recall involves the following:

Prescription Prenatal Vitamin Products:
Advanced NatalCare® Tablets
Advanced-RF NatalCare® Tablets
Cal-Nate™ Tablets
CareNatal™ DHA Tablets
ComBgen Tablets
ComBiRx™Tablets
NataCaps Capsules
NatalCare Gloss Tablets
NatalCare PIC Tablets
NatalCare PIC Forte Tablets
NatalCare Plus Tablets
NatalCare Rx Tablets
NatalCare Three Tablets
NataTab FA Tablets
NataTab RX Tablets
NutriNate® Chewable Tablets
NutriSpire™ Tablets
Prenatal MR 90 FE Tablets
Prenatal MTR w/Selinium Tablets
Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
Ultra NatalCare Tablets

Prescription Iron Supplement Products:
Anemagen Caplets
Anemagen Forte Caplets
Conison™ Capsules
Fe-Tinic™ 150 Forte Capsules

This recall has been issued at the wholesale/retail level. An ETHEX press release said patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications 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.

ETHEX Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products. Any wholesaler 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.

Just last week, the problems at KV Pharmaceuticals prompted ETHEX to recall scores of generic drugs that might be defective. In December, the drug maker recalled a single lot of Hydromorphone HCl 2 mg tablets because some of them may have been oversized. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. Those medications included various lots and sizes of Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets and Dextroamphetamine Sulfate Tablets. That action followed an October recall of three lots of potentially oversized Dextroamphetamine Sulfate. And in June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.

ETHEX Recalls More Oversized Drugs

Wed, 24 Dec 2008 00:00:00 -0800

ETHEX Corp. has announced another recall of oversized tablets. This time, the company is recalling a single lot of Hydromorphone HCl 2 mg tablets. According to the Food & Drug Administration (FDA), Hydromorphone is a drug used for pain management and is packaged under the ETHEX label in 100-count bottles.

The ETHEX Hydromorphone recall involves Lot #90219, Exp: 03/2010; NDC #58177-0620-04. ETHEX has initiated recall notifications to wholesalers and retailers nationwide who have received any inventory of the recalled lot of this product with instructions for returning the recalled product. If they have not already done so, they are urged to contact ETHEX regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call ETHEX or their physician, pharmacist, or other health care provider.

The FDA has warned that if someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased. Possible side effects of Hydromorphone overdose include respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation.

This is the fourth time this year that ETHEX has recalled a product because of an overdose risk. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. Those medications included various lots and sizes of Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets and Dextroamphetamine Sulfate Tablets.

In October, ETHEX recalled three lots of potentially oversized Dextroamphetamine Sulfate. And in June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.

In conjunction with this recall, the parent company of ETHEX Corporation, KV Pharmaceutical, has advised the FDA that, effective midnight Dec. 19, 2008, the company voluntarily suspended shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to expeditiously address manufacturing issues that have come to management’s attention, to review and enhance comprehensively the company’s quality systems, and to implement efficiency improvements in its production facilities.

Any customer inquiries related to this latest recall should be addressed to ETHEX Customer Service at 1-800-748-1472 or fax to ETHEX Customer Service at 314-646-3751, or e-mail to customer-service@ETHEX.com. Representatives are available Monday through Friday, 8 am to 5 pm CST. Consumers who experience any adverse reactions to this drug should contact their physician and/or healthcare provider immediately.

Another ETHEX Generic Drug Recall

Mon, 10 Nov 2008 00:00:00 -0800

Generic drug maker ETHEX Corporation has initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as twice the expected dosage.

This is the third time ETHEX has recalled generic drugs for this reason. In June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized. Last month, ETHEX recalled three lots of potentially oversized Dextroamphetamine Sulfate.

According to the Food & Drug Administration (FDA), this new ETHEX recall includes the following generic medications:

Propafenone HCl Tablets, 150 mg: 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. 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: 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. 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: 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. 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: 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. Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009
Isosorbide Mononitrate Extended Release Tablets, 60 mg: 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. Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009
Morphine Sulfate Extended Release Tablets, 15 mg: The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with "15" on one side and an "E" on the reverse. 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: 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. 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: 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. 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: 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. Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

According to the FDA, 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.

Consumers who have questions regarding the ETHEX generic drug recall should call their physicians or pharmacist. They may also contact ETHEX Customer Service at 1-800-748-1472. Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.

All of the generic drugs involved in this latest recall were shipped prior to May 22, 2008. 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.

Ethex Corporation Recalls Three Lots of Dextroamphetamine Sulfate

Thu, 16 Oct 2008 00:00:00 -0700

The Ethex Corporation just announced it has voluntarily recalled three lots—77946, 81141, and 81142—NDC #58177-311-04—of Dextroamphetamine Sulfate 5 mg tablets. The recall was initiated due to the possible presence of oversized tablets that were distributed by Ethex Corporation under an "ETHEX" label dated between January 2007 and May 2008. The 5 mg product is an orange round tablet “debossed” with "ETHEX" and "311" on one side.

Dextroamphetamine Sulfate is an amphetamine, a central nervous system stimulant, and a Schedule II drug used in the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) and in the treatment of Narcolepsy. The oversized tablets may contain as much as twice the labeled amount of the active ingredient, which means that if one were to take a higher-than-expected dose of Dextroamphetamine Sulfate, the risk of adverse effects known to be associated with the drug may be increased. Such adverse events include tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth.

Ethex discovered and removed a small number of oversized tablets in lots not yet distributed; however, because there are multiple companies in the U.S. producing and marketing generic versions of Dextroamphetamine Sulfate 5 mg tablets, patients and caregivers are urged to check their prescriptions to determine the source of their tablets. Ethex Corporation sent notifications and return instructions to wholesalers and retailers nationwide who received inventory of the recalled lots. Patients and caregivers should not use any Dextroamphetamine Sulfate tablets that appear oversized.

This is not the first time that Ethex has had to initiate a recall such as this. In early June, Ethex recalled its morphine sulfate tablets after receiving a report of a tablet that was twice the normal size, which meant that a larger tablet could contain twice the active ingredient, putting users at risk of morphine overdose. At that time, Ethex recalled only a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762). The defective tablets were distributed under an “ETHEX” label between April 16th and April 27th of 2008. The recalled product was a white oval tablet with “60″ on one side, and “E” on the reverse. Ethex did not say why it failed to recall all of its potentially defective morphine tablets in the initial recall; however, this oversight likely put thousands of morphine users in unnecessary danger. Finally, one week later, Ethex announced that it was expanding its morphine tablet recall to include several lots of 60 mg and 30 mg extended release tablets.

Morphine overdose is characterized by a variety of symptoms including pinpoint pupils, nausea and vomiting, weak pulse, and low blood pressure. A person suffering from morphine overdose will also have difficulty breathing, and may exhibit shallow or labored breathing. They may also stop breathing for short periods of time and their lips and fingertips might also turn a bluish color. If they do not receive medical attention quickly, a person who has overdosed on morphine can experience seizures, fall into a coma, and possibly die.

Ethex Lawyer Morphine Recall Lawsuit Overdose

Thu, 16 Oct 2008 00:00:00 -0700

Ethex Morphine Tablet Recall Lawyers

Keywords: Ethex | Lawyer | Morphine | Recall | Lawsuit | Overdose

The lawyers and attorneys at our firm are currently offering free case evaluations to people injured by morphine sulfate tablets distributed by Ethex Corp. Ethex Corp. recalled its morphine sulfate tablets after receiving a report of a tablet that was twice the normal size. There is a chance that a larger tablet could contain twice the active ingredient, putting users at risk of morphine overdose. If you or someone you know suffered symptoms of overdose as a result of one of these tablets, we urge you to contact our Ethex morphine injury lawyers as soon as possible to discuss your case.

Ethex Morphine Tablet Recalls

On June 9, 2008, Ethex Corp. recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762). The defective tablets were distributed under an “ETHEX” label between April 16th and April 27th of 2008. The recalled product was a white oval tablet with “60″ on one side, and “E” on the reverse.

No other dosage strength, nor any other lot of the 60 mg strength was affected by this recall. The Ethex morphine injury lawyers at our firm believe the limited scope of this recall was not adequate to insure that all defective morphine tablets were removed from the market.

On June 13, 2008, Ethex Corp. announced that it was expanding its morphine tablet recall to include several lots of 60 mg and 30 mg extended release tablets. The 60 mg product is a white oval tablet with “60” on one side, and “E” on the reverse. The 30 mg product is a pink oval tablet with “30” on one side, and “E” on the reverse. Morphine pills included in the expanded recall were distributed between June 2006 and May 2008.

The expanded Ethex morphine tablet recall included the following:

Morphine Sulfate ER 30mg Tablet/NDC # 58177-320-04: Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284
Morphine Sulfate ER 60mg Tablet/NDC # 58177-330-04: Lots 91762 (previously reported), 75091, 75092, 77848 through 77851, 82517, 82518, 83333, 83817, 83862, 84111, 84112, 84315, 84900, 85326, 85335, 85807, 86270 through 86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260 through 90272, and 91763 through 91765.

Ethex did not say why it failed to recall all of its potentially defective morphine tablets in the initial recall. However, this oversight likely put thousands of morphine users in unnecessary danger. Our Ethex morphine injury lawyers intend to make sure the company is held accountable for any injuries that might have occurred because of this failure.

Morphine Overdose

At the time of both morphine tablet recalls, Ethex characterized the actions as precautionary. The company has maintained that it received no reports of unexpected side effects or injury. However, not all adverse drug reactions are reported, and our Ethex morphine injury lawyers suspect that these defective tablets have injured many people.

Opioids, such as morphine, have life-threatening consequences if overdosed. Many patients who are prescribed Ethex morphine tablets are likely to be highly debilitated with reduced strength or energy as a result of illness. As such, they may not be able determine that a tablet is overweight or oversized.

Morphine overdose is characterized by a variety of symptoms. These include pinpoint pupils, nausea and vomiting, weak pulse and low blood pressure. A person suffering from morphine overdose will also have difficulty breathing, and may exhibit shallow or labored breathing. They may also stop breathing for short periods of time. Their lips and fingertips might also turn a bluish color. If they do not receive medical attention quickly, a person who has overdosed on morphine can experience seizures, fall into a coma, and possibly die. The Ethex morphine injury lawyers will make sure that anyone who suffered a morphine overdose because of these defective tablets receives the compensation they deserve.

Legal Help for Victims of Recalled Ethex Morphine Tablets

If you or someone you love suffered the symptoms of morphine overdose after taking a recalled Ethex morphine tablet, you have valuable legal rights. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) to discuss you case with an experienced Ethex morphine injury lawyer .