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KV Pleads Guilty, Agrees to Close Ethex Generic Drug Plant

We have long been writing about a series of problems with K-V Pharmaceutical Company. In December, K-V Pharmaceutical said that the U.S. Food and Drug Administration (FDA) accepted its work plan to address the issues. Now, KV Pharmaceutical said it will be closing down its Ethex generic drug unit, wrote The Associated Press (AP). The drug maker will also plead guilty to criminal charges that allege Ethex neglected to appropriately advise regulators about significant manufacturing problems that posed dangers to consumers, wrote the AP.

Last March, we wrote that the U.S. Food and Drug Administration (FDA) announced that a Consent Decree of permanent injunction was filed enjoining KV Pharmaceutical Company, its subsidiaries Ethex Corporation and Ther-Rx Corporation, and its principal officers, from making and distributing adulterated and unapproved drugs. That move followed an extensive series of incidents regarding KV Pharmaceuticals and its subsidiaries.

Prior to that, Ethex expanded an earlier generic drug recall. Like other Ethex recalls from the prior several months, the expanded recall was necessary because of an array of manufacturing problems and involved a variety of medications, all of which had been issued at the wholesale level and which were expanded to the retail level. The recall was implemented because the products might have been manufactured under conditions that did not sufficiently comply with the FDA’s current Good Manufacturing Practice (cGMP) regulations.

Because of the manufacturing problems cited by the agency, Ethex issued several recalls in 2008. In January, Ethex issued a recall of its prescription infant vitamins and prescription iron supplements; also, problems at KV Pharmaceuticals prompted Ethex to recall scores of generic drugs that might have been defective.

In December 2009, the drug maker recalled a single lot of Hydromorphone HCl 2 mg tablets because some may have been oversized. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. That action followed an October recall of three lots of potentially oversized Dextroamphetamine Sulfate. In June, Ethex recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.

The FDA inspected KV between December 2008 and February 2009, and found it to have significant cGMP violations while continuing to manufacture unapproved drugs.

Now, KV is planning on shutting down Ethex Corporation because, following the plea, it will likely be excluded from government programs and will be paying about $27.6 million to resolve the government probe, said the AP, which added that charges relate to the firm’s failure “to file field alerts, or urgent notices about potential safety threats,” with the agency, specifically with dextroamphetamine, an ingredient Adderall, and propafenone, a cardiac medication. Adderall is prescribed in the treatment of Attention Deficit and Hyperactivity Disorder (ADHD). The payment includes fines and restitution totaling $25.8 million and $2.3 to the federal government; Ethex is not expected to contest an administrative forfeiture of $1.8 million, added the AP, citing KV.

CEO Marc Hermelin recently stepped down after a nearly 30-year career with the drug maker, the AP noted.

FDA Takes Action Against KV Pharmaceuticals

The U.S. Food and Drug Administration (FDA) just announced that a Consent Decree of permanent injunction was filed yesterday enjoining KV Pharmaceutical Company, its subsidiaries Ethex Corporation and Ther-Rx Corporation, and its principal officers, from making and distributing adulterated and unapproved drugs.

This is the most recent in an extensive series of incidents regarding KV Pharmaceuticals and its subsidiaries. Early last month, Ethex expanded a prior generic drug recall. Like other Ethex recalls from the previous several months, the expanded recall was necessary because of manufacturing problems and involved a variety of medications, all of which had been issued at the wholesale level and were expanded to the retail level. The recall was implemented because the products might have been manufactured under conditions that did not sufficiently comply with the FDA’s current Good Manufacturing Practice (cGMP) regulations.

In January, 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 issued several recalls last year. In January, Ethex issued a recall of its prescription infant vitamins and prescription iron supplements; also, problems at KV Pharmaceuticals prompted Ethex to recall scores of generic drugs that might have been defective.

In December, the drug maker recalled a single lot of Hydromorphone HCl 2 mg tablets because some may have been oversized. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. That action followed an October recall of three lots of potentially oversized Dextroamphetamine Sulfate. In June, Ethex recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.

Now, the injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval and will remain in place until the defendants sustain continuous—five-year—compliance with FDA's cGMP and new drug approval requirements. The Consent Decree also enjoins KV’s officers David A. Van Vliet, president and chief executive officer; Rita E. Bleser, president of the pharmaceutical division; Jay S. Sawardeker, vice president of corporate quality; and Marc S. Hermelin, former chief executive officer and a member of KV's Board of Directors, from manufacturing and distributing any drug at or from KV’s facilities until such time that the company's procedures and products are brought into compliance with the law.

The FDA inspected KV between December 2008 and February 2009, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. “The FDA requires companies to manufacture drugs in accordance with the current good manufacturing practice standards and to comply with FDA approval requirements,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that drugs meet our manufacturing requirements for identity, strength, purity, and quality, and have been evaluated by the FDA for safety and efficacy.”

Under the terms of the Consent Decree, the defendants cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspections of the facilities and certify compliance with the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and the Decree. The Decree requires the defendants to destroy all drugs recalled between May 2008 and February 3, 2009; those drugs are currently in the defendents’ possession.

If the defendants fail to comply with any provision of the Decree, the Act, or FDA regulations, the FDA may order the firm to again stop manufacturing and distributing drugs, recall the products, or take other corrective actions. The Decree subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the Decree’s provisions, and the payment of an additional $15,000 per violation, up to $5 million annually. “The FDA will carefully monitor the provisions of this injunction against the KV Pharmaceutical Company to ensure compliance,” said Michael Chappell, the acting associate commissioner of FDA’s Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs."

Ethex Generic Drug Recall Expanded

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

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).

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 Issues Massive Recall of Generic Drugs

Ethex Corp. � is recalling scores of generic drugs that might be defective. The recall is part of a larger action taken by KV Pharmaceuticals - the parent of Ethex Corp. - which we reported on earlier this week.

According to an Ethex press release, the massive � recall is necessary because the medications � may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. � Some of the medications have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. � Ethex said the additional products are being removed to assure that no other defective products remain in the marketplace.

The Ethex recalls is taking place at both the retail and wholesale level. � Drugs recalled at the retail level include:

Hydromorphone HCl Tablets, 2mg (Lot #s 58177-620-04 & 620-11)

Hydromorphone HCl Tablets, 4mg (Lot #s 58177-621-04 & 621-11)

Hydromorphone HCl Tablets, 8mg (Lot #s 58177-449-04)

Metoprolol Succinate ER Tablets, 50mg (Lot #s 58177-369-04, 369-09 & 369-11)

Metoprolol Succinate ER Tablets, 100mg (Lot #s 58177-368-04, 368-09 & 368-11)

Metoprolol Succinate ER Tablets, 25mg (Lot #s 58177-293-04, 293-09 & 293-11)

Metoprolol Succinate ER Tablets, 200mg (Lot #s 58177-358-04, 358-09 & 358-11)

Ethex said that 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. A complete list of the drugs recalled by Ethex are available here.

Earlier this week, KV Pharmaceuticals suspended manufacturing and shipping of all of its products, including those made by its subsidiary, Ethex. � That � announcement followed an inspection that began in December by the U.S. Food and Drug Administration of the company's operations and inventory.

Ethex has also issued multiple recalls this year because of production problems related to the KV shutdown. � 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

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

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 Corp. Recalls Three Lots of Dextroamphetamine Sulfate

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 Morphine Tablet Recall Expanded

A recall of potentially over-sized morphine tablets has been expanded by Ethex Corp. � � The recalled morphine tablets could contain as much as twice the amount of active ingredient than is safe, putting users at risk of morphine overdose.

Ethex first recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) last Monday. � The recall was issued after Ethex received a report of one oversized morphine tablet in the affected lot.

Now, the Ethex morphine recall has been expanded to include several lots of 60 mg and 30 mg extended release tablets. � According to the Food & Drug Administration (FDA) the recalled lots include:

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.

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.

Ethex is characterizing the additional morphine tablet recall as a precaution, and says that no additional oversized tablets have been identified in the affected lots. � No report of unexpected side effects or injury has been received. � However, opioids such as morphine, have life-threatening consequences if overdosed. � Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure, apnea, and hypotension.

This is the second time in less than two months that a prescription tablet has been recalled because it contained twice the active ingredient than what was listed on the label. � In April, Actavis Towtowa recalled Digitek tablets because some of the medication was manufactured at twice the normal strength. According to the FDA, the Digitek defect could cause serious and even fatal reactions in user, and the agency deemed the action a Class I recall. � According to the agency, there have been several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports.

Morphine Tablets Recalled for Overdose Risk

Morphine tablets are being recalled because of a potential manufacturing defect. � Ethex Corp., the manufacturer of the recalled morphine tablets, has received a report of a tablet that was twice the appropriate thickness. � A thicker tablet may contain twice the amount of morphine sulfate than is stated on the product label, putting users at risk of accidental morphine overdose.

According to the Food & Drug Administration (FDA), the recall involves 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. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall. � The product is a white oval tablet with "60" on one side, and "E" on the reverse.

The FDA has not received any reports of unexpected side effects or injury thus far. However, opioids such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness. As such, they may be less likely to be able to determine that a tablet is overweight or oversized than an unimpaired individual.

Any customer inquiries related to this action should be addressed to Ethex Customer Service at 1-800-321-1705, 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 am to 5 pm CST.

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