Hydrocodone 10 mg/Acetaminophen 500 mg Tablets
September 25, 2012
Watson is issuing a voluntary, retail level recall on two lots of hydrocodone bitartrate 10 mg /acetaminophen 500 mg tablets. Tablets in lots 519406A and 521759A may exceed weight specifications and contain increased amounts of hydrocodone bitartrate and acetaminophen. Patients receiving increased doses of acetaminophen may be at an increased risk for liver toxicity. This risk is increased in patients who consume three or more alcoholic beverages per day or have liver dysfunction. Additionally, patients receiving increased doses of hydrocodone bitartrate may have a higher frequency of adverse effects such as respiratory depression or somnolence.
The affected lot was distributed to wholesalers and pharmacies between June 27 and July 18, 2012. The tablets are blue and capsule-shaped, with a “Watson 540” on one side. Immediately stop dispensing product from lots 519406A and 521759A, and quarantine if found in inventory. Pharmacists may contact Genco Pharmaceutical Services at 1-800-950-5479 for directions on returning affected product. Consumers should consult their pharmacy or healthcare provider if they suspect they may possess affected product. Healthcare professionals and consumers may call Watson at 1-800-272-5525 for additional information.
Report any adverse event to the FDA online at www.fda.gov/MedWatch/report.htm, or by phone at 1-800-332-1088.
Additional information on this recall is available from the following links:
- MedWatch Alert
- Recall Press Release
September 24, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.