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ETHEX Recalls More Oversized Drugs

Dec 24, 2008 | Parker Waichman Alonso LLP

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.