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Watson Issues Voluntary Nationwide Recall Of Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 Mg/500 Mg Due To The Potential For Oversized And Superpotent Tablets

Stocks in this article: WPI

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 Tablets, USP 10 mg/500 mg, 500 count NDC 00591-0540-05, Lot Numbers 519406A and 521759A both with the expiry date April 2014.

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.

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