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Watson Recalls Two Lots of Abnormal Hydrocodone Bitartrate and APAP Tablets

On September 20, 2012, Watson Laboratories Inc. voluntary recalled two lots of Hydrocodone Bitartrate and APAP (acetaminophen) tablets after receiving a report from a customer pointing out an abnormal set of tablets. According to the U.S. Food and Drug Administration, the medicine appeared thicker and darker than normal. The cause tablet irregularity is unknown; however, Watson Laboratories Inc. is making a nationwide recall these products to avoid possible overdose of the medicines since the tablets may contain more Hydrocodone Bitartrate and acetaminophen) than indicated.

Which  Hydrocodone Bitartrate and Acetaminophen Products Were Recalled?

watson 540 Hydrocodone Bitartrate and acetaminophen tablet

Hydrocodone Bitartrate and acetaminophen tablet shown above.

The effected medications include Hydrocodone Bitartrate and acetaminophen tablets of 10 mg/500 mg. The recalled products were released from lot numbers 519406A and 521759A between June 27, 2012 and July 18, 2012. The medicine comes in a 500 count package with an expiration date of April 2014. The tablets may be identified as blue, bisected oval or capsule-shaped tablets labeled “Watson 540” on one side.

What to Do with Recalled Products

If you are a consumer and have any recalled Hydrocodone Bitartrate and acetaminophen tablets in your possession, contact your healthcare provider to report the product. Because of the possibility of accidentally taking more than prescribed, patients should not use recalled medicine. Taking recalled medicine can result in serious, adverse side effects such as:

  • liver damage or toxicity
  • respiratory depression
  • magnification of side effects
  • death

Patients who have experienced a serious side effect should report their case by calling Watson Laboratories at 1-800-272-5525 or the FDA MedWatch Program online at http://www.fda.gov/medwatch/report.htm, by faxing 1-800-FDA-0178, or by mailing the FDA at the address listed at http://www.fda.gov/MedWatch/getforms.htm.