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FDA - Recall of a Single Lot of Hydromorphone

Started by ronr, December 24, 2008, 09:45:19 AM

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ronr

Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet
Contact:
Ann McBride
1-800-748-1472

FOR IMMEDIATE RELEASE -- St. Louis, MO – December 23, 2008 – ETHEX Corporation announced today that it has voluntarily recalled to the consumer level, a single production lot of Hydromorphone HCl 2 mg tablets (Lot #90219, Exp: 03/2010; NDC #58177-0620-04), as a precaution, due to the possibility it may contain oversized tablets. Hydromorphone is a drug used for pain management and is packaged under the ETHEX label in 100-count bottles.

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, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation.

There are other companies in the United States producing and marketing versions of Hydromorphone HCl tablets and consumers and their caregivers are encouraged to check their prescriptions to determine the source of their tablets. Hydromorphone HCl 2 mg tablets marketed by ETHEX are a blue, round tablet with a script "E" on one side and a "2" on the other side.

ETHEX Corporation 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 and, if they have not already done so, they are urged to contact ETHEX as provided below regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the telephone number below or their physician, pharmacist, or other health care provider.

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 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. Any adverse reactions experienced with the use of this product, 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.

The Hydromorphone HCl recall announcement is posted on www.kvpharmaceutical.com and www.fda.gov/opacom/7alerts.html. It includes step-by-step details on how to return affected product to KV Pharmaceutical. The Company web site also includes a list of the drugs affected by the suspension.

The parent company of ETHEX Corporation, KV Pharmaceutical has advised the U.S. Food and Drug Administration 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. KV is keeping the FDA informed about the Company's plans.

This recall and suspension are being conducted with the knowledge of the FDA. At this time, the company is unable to determine when distribution of tablet form products will resume, or estimate what the financial impact of the recall and suspension will be.

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http://www.fda.gov/oc/po/firmrecalls/ethex12_08.html
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