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Carol Eustice

Update on Voluntary Recall of Hydrocodone Bitartrate / Acetaminophen Tablets

By January 1, 2013

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In early December 2012, Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary nationwide recall for 101 lots of hydrocodone bitartrate/acetaminophen tablets, USP 10 mg/500 mg. The recall included products with NDC numbers listed on the FDA website and lot numbers beginning with the letter "C". The reason given for the recall was that some of the tablets from the affected lots may exceed the weight requirement and thereby contain more hydrocodone or acetaminophen than stated on the label.

The affected lots were distributed between February 20, 2012 and November 19, 2012 to wholesale distributors and retail pharmacies across the country. The lot number can be found on the side of the manufacturer's bottle. The affected hydrocodone bitartrate/acetaminophen tablets are pink, capsule-shaped tablets, with "3600" debossed on one side and "V" on the other side of the tablet. Consumers who have the affected lots have been advised to contact Qualitest at 1-800-444-4011 -- or if consumers are unsure if they have the affected lot numbers, they should consult their pharmacy.

On December 21, 2012, it was announced that three more lots of hydrocodone bitartrate/acetaminophen were being recalled by Mylan Institutional. The FDA reports that the three lots were manufactured by Qualitest Pharmaceuticals and repackaged and distributed by Mylan Institutional. The three lot numbers are 3037841, 3040859, 3042573. If you have tablets from these lot numbers, you can contact Mylan Customer Service at 1-800-848-0462. If you are unsure about your product, contact your pharmacy. Do not panic, but be aware that taking higher than intended doses of the drug could potentially cause problems as explained by the FDA.

Hydrocodone bitartrate/acetaminophen are the generic ingredients found in brand name analgesic medications, such as Vicodin or Lortab. Analgesics are often used by arthritis patients to control pain. The brand name drugs are not involved in the recall.

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Photo by David Sucsy (iStockphoto)

February 5, 2013 at 8:11 pm
(1) Susie says:

Where ia quality control?This has happened before,same co.

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