Generic Phenobarbital and Vicodin Recall Issued After Labeling Mix-Up

Some bottles of generic Vicodin and Phenobarbital may have the wrong label, which could lead to drug overdoses, unexpected side effects, and patients not getting the medication they require. 

Last week, the FDA announced a Qualitest Pharmaceuticals generic Vicodin and Phenobarbital recall due to the labeling mix-up. The recall came after a bottle of generic Vicodin was found with a Phenobarbital label.

The FDA and Qualitest warn that accidental ingestion of a generic Vicodin (hydrocodone bitartrate and acetaminophen) could lead to serious side effects, including respiratory depression, CNS depression, coma and death. It could also cause liver toxicity when taken with other drugs that include acetaminophen or among patients with liver problems or those who drink more than three alcoholic beverages a day. It could also cause patients who should be taking Phenobarbital to suffer seizures.

The recall affects three lots of 60-count bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg. The pills have an NDC number of 0603-3888-20. The lot numbers are T150G10B, T120J10E and T023M10A. The recall also affects three lots of 1,000-count bottles of Phenobarbital Tablets, USP 32.4 mg. They have an NDC number of 0603-5166-32 and the lot numbers are T150G10B, T120J10E and T023M10A.

The FDA recommends that consumers using generic Vicodin and Phenobarbital visually verify that they have been taking the correct pills. The generic Vicodin pills affected by the recall are large pink, capsule-shaped and have 3600 debossed into the pill on one side and a V debossed into the pill on the other side. Phenobarbital pills are less than half that size, and are white, round, scored tablets with 5012 debossed on one side and a V debossed on the other.

Qualitest has said that it is notifying all customers who may have received an incorrectly labeled bottle of pills to arrange for their return. There have been no reports of injury or death associated with the mix-up.

The recall comes just a month after 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. Acetaminophen is the main ingredient in Tylenol and used in many cold medicines, but it is also often combined with powerful painkillers.

Vicodin and generics that use the same active ingredients are prescribed more than 100 million times a year in the United States. However, safety issues are a serious concern, as more than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen.