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U.S. Department of Health and Human Services

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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.

 

KV Pharmaceutical Voluntarily Suspends All Shipments of its Approved Tablet-form Drugs

Initiates Nationwide Single Lot Recall of Hydromorphone HCl (2mg) Due to Oversized Tablet

 

Contact:
Catherine Biffignani
(314) 645-6600

 

FOR IMMEDIATE RELEASE --ST. LOUIS - Dec. 23, 2008 - KV Pharmaceutical has advised the U.S. Food and Drug Administration (FDA) that, effective midnight Dec. 19, 2008, the company voluntarily suspended all shipments of all FDA approved drug products in tablet form. KV Pharmaceutical is also recalling a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following the report of an oversized tablet. Additional details on this recall were provided in an ETHEX Corporation press release also issued today and will be posted on www.kvpharmaceutical.com.

At this time, the company is unable to determine when distribution of tablet-form products will resume.

A full list of products included in the suspension of shipments can be viewed on the Company's website at www.kvpharmaceutical.com, where a link can be found on the home page to "Products Effected by Shipment Suspension".

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