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ETHEX Generic Drug Recall Expanded

Feb 5, 2009 | Parker Waichman Alonso LLP

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.