Oversized, Super-potent Hydrocodone and Acetaminophen Recall

September 24, 2012 — The U.S. Food and Drug Administration (FDA) and Watson Laboratories, Inc. have announced a voluntary nationwide recall of some lots of hydrocodone and acetaminophen (APAP) tablets. The products are marked with USP 10-mg/500-mg, Lot Number 519406A and 521759A, expiration date April 2014, and they were sold throughout the United States by pharmacies and retailers from June 27, 2012 until July 18, 2012.

The problem was first identified by a consumer who reported receiving a tablet that was larger and darker than normal hydrocodone / acetaminophen. The FDA is concerned that the products may have been manufactured with higher amounts of hydrocodone and/or acetaminophen that exceeds their weight limit specifications.

The FDA is concerned that taking a pill with excessive amounts of the drugs could cause a severe, potentially life-threatening adverse event. One of the most severe adverse events is liver toxicity. This side effect is especially likely in patients who are taking multiple medications containing acetaminophen, or those who have liver problems, or patients who consumes more than 3 alcoholic beverages per day. There is a risk that severe liver toxicity could cause liver damage or failure, which may require liver transplant.

Using an excessive amount of hydrocodone could also potentially cause severe adverse events — including sedation and poor respiration. These severe side effects are most common in elderly patients, people with kidney problems, impaired liver function, or people who are taking other sedative medications or antidepressants.

The FDA is recommending that patients and pharmacies check to see whether they have purchased hydrocodone with acetaminophen lots 519406A or 521759A. These products should not be used, and they should be segregated from other medications to prevent accidental use.

This is the second recall of hydrocodone in September 2012. The last recall was issued in September 11, 2012, when Qualitest recalled one lot of hydrocodone (USP 10 mg/500mg) because bottles from the lot could contain tablets with higher amount of acetaminophen.

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