Watson Issues Voluntary Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to …

PARSIPPANY, N.J., Sept. 21, 2012 /PRNewswire/ --Watson Laboratories, Inc. today issued a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg. A customer complaint was received for tablets that were thicker and darker shade than the other tablets. It is possible that some tablets from lots 519406A and 521759A exceed the weight specification and may contain higher than indicated amounts of the ingredients Hydrocodone Bitartrate and/or Acetaminophen.

Unintentional ingestion of excessive amounts of acetaminophen may potentially result in an adverse event, including liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death. Unintentional ingestion of excessive amounts of hydrocodone may result in an adverse event, including an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants. No reports of injuries related to the recalled product have been received to date.

The recall includes the following product lots:

Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain. The affected lots were distributed between 6/27/2012 and 7/18/2012 to wholesale distributors and retail pharmacies nationwide. The lot numbers can be found on the manufacturer's bottle label. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 0.6 inches in length, blue, bisected capsule shaped, with "Watson 540" de-bossed on one side of the tablet.

Consumers who have lots 519406A or 521759A should contact their pharmacy or health care professional. Consumers who are unsure if they have the affected lot numbers should consult their pharmacy or health care professional.

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 1-855-393-5728 for instructions on product return. Pharmacies that received lots 519406A or 521759A will receive a copy of this press release with their recall notification information. In order to make your patients aware of this recall, please post the enclosed press release prominently in the pharmacy area.

For more information please contact Watson Laboratories at 1-800-272-5525; Monday through Friday between the hours of 8 a.m. and 5 p.m. EST. Reports of adverse reactions or quality problems can also be reported to Watson Laboratories at 1-800-272-5525.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

About Watson Pharmaceuticals, Inc.

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Watson Issues Voluntary Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to ...