Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Recalled due to Potential for Oversized Tablets leading to Overdose

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The US FDA informs Pharmacy healthcare personnel that Hydrocodone Bitartrate and Acetaminophen Tablets are recalled because there is a potential for oversized and superpotent tablets that can lead to overdose.

Background of Hydrocodone Bitartrate and Acetaminophen Tablets

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, by Watson Laboratories Inc., are indicated for the relief of moderate to moderately severe pain. FDA Alert on Hydrocodone Bitartrate and Acetaminophen Tablets

FDA’s reason for the recall is that, according to a complain, Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg were thicker and darker shade than the other tablets and may contain higher than indicated amounts of the active ingredients.

This can lead to overdose causing severe adverse events including liver toxicity, sedation or respiratory depression.

The affected lot numbers are 519406A and 521759A, with expiration date April 2014. They were distributed to retail pharmacies and wholesale distributors from 6/27/2012 to 7/18/2012.

Recommendation on Hydrocodone Bitartrate and Acetaminophen Tablets

“Pharmacists and wholesalers are asked to check their inventories for lots 519406A or 521759A segregate any material from the lots, and to contact GENCO Pharmaceutical Services at 1-800-950-5479 for instructions on product return.”

Contacting the FDA to report cases with Hydrocodone Bitartrate and Acetaminophen Tablets

In case of detection of adverse events or side effects related to the use of Hydrocodone Bitartrate and Acetaminophen Tablets, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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