FDA Issues Recall On Three Lots Of Hydrocodone and Acetaminophen Tablets

February 14, 2013

The U.S. Food and Drug Administration (FDA) along with drug manufacturers, Qualitest Pharmaceuticals and Mylan Institutional, has announced the recall of several lots of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg. According to an FDA press release, the recall is being conducted due to defects in the medications that could lead to consumers suffering certain drug injuries.

In December of last year, the companies received reports that testing of three lots of the medications concluded some tablets weighed more than the established standard, meaning some of the tablets may have contained more of the active ingredient found in the medications than they were supposed to. Such a mistake could lead to a patient ingesting more of the drug than they are supposed to, which could result in the common Acetaminophen Drug Injury, known as acute liver toxicity. Patients most at risk are those who are already taking acetaminophen-based drugs, those who consume more than three alcoholic beverages per day, and those already suffering from liver dysfunction.

The affected lot numbers include:

  • 3037841
  • 3040859
  • 3042573

Anyone in possession of the affected drugs has been instructed to contact the manufacturer about how to dispose of the affected medications and the steps for receiving a replacement or refund.

The Pennsylvania Personal Injury Lawyers with Lundy Law are recognized for handling drug injury litigation and urge anyone who has been harmed by a medication prescribed to them by a doctor to discuss their legal options with a qualified attorney.