Qualitest Generic Vicodin and Fioricet Recall: Label Mix Up

Federal drug regulators are warning that some bottles of Qualitest generic Vicodin and Fioricet may have had their labels swapped due to a manufacturing problem, meaning that some patients could be taking the wrong drugs. 

A Qualitest generic drug recall was announced on June 27 after at least one bottle of generic Fioricet was found with a generic Vicodin label.

The FDA and Qualitest warn that unintentional Fioricet consumption by people with an allergy to butalbital, one of its active ingredients, could result in a hypersensitivity reaction. They also warn that those who were already on Vicodin could experience increased pain and withdrawal symptoms. There were no reports of anyone having suffered adverse events due to the labeling mix-up.

Fioricet is a combination drug that includes butalbital, acetaminophen and caffeine. Butalbital is a barbiturate and acetaminophen is the active ingredient in Tylenol. It is approved for the treatment of tension headaches and muscle contraction headaches.

Vicodin (hydrocodone and acetaminophen) is a powerful opioid painkiller approved to relieve moderate to severe pain. It and generics that use the same active ingredients are prescribed more than 100 million times a year in the United States.

The recall affects four lots of 500-count bottles of Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, by Qualitest. The lot numbers are C0390909A, C0400909A, C0410909A, and C0590909B, and the bottles have NDC 0603-2544-28. It also affects four lots of 1,000-count bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, by Qualitest, with lot numbers C0390909A, C0400909A, C0410909A, and C0590909B, and NDC 0603-3882-32. The lots were distributed between November 13, 2009 and April 9, 2010.

The FDA recommends that any consumers who received a prescription from either affected medications check to visually ensure they have the right pills. The generic Fioricet pills are white, have 2544 stamped into them on one side and a “V” on the other and are 11 mm in diameter. The generic Vicodin pills are 16.5 mm in length and are white with green specks, capsule shaped with 3594 stamped on one side, as well as a “V” on the other side.

This is the second time this year Qualitest has had to recall generic Vicodin and a barbiturate due to a label mix-up. On February 5, 2011, three lots of generic Vicodin and Phenobarbital were recalled after a bottle of Vicodin was found with a Phenobarbital label. 

In January, the FDA announced that it was placing limits on the amount of acetaminophen in Vicodin, Percocet and similar painkillers. The agency is also requiring stronger label warnings regarding the risks of liver injury.