Generic Vicodin Recall Issued Due to Risk of Overdose

A recall has been issued for one lot of generic Vicodin tablets manufactured by Qualitest, due to a risk that they may contain too much of the active ingredients, hydrocodone or acetaminophen, which could pose a risk of overdose for consumers. 

The Qualitest Vicodin recall was announced on September 10, after the manufacturer realized that some of the tablets may exceed the weight specifications.

A hydrocodone or acetaminophen overdose could pose a serious and potentially life-threatening risk for consumers. However, the manufacturer indicates that there have been no reports identified of drug overdose or injury due to the oversized pills.

The recall affects Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, with an expiration date of 12/13. The recalled lot was distributed between May 14 and August 3 nationwide. The pills are pink, capsule-shaped, with “3600” debossed on one side and “V” debossed on the other.

Vicodin (hydrocodone and acetaminophen) is a powerful opioid painkiller approved to relieve moderate to severe pain. The brand name version of the drug and generic equivalents that use the same active ingredients are prescribed more than 100 million times a year in the United States.

The hydrocodone component is an opioid painkiller, also known as an opioid pain reliever (OPRs). It is part of a class of analgesis medications that also includes methadone, oxycodone and morphine. All are powerful controlled substances that can be cause respiratory depression, extreme sedation and death if taken in high quantities.

Acetaminophen is the active pharmaceutical ingredient in Tylenol and a number of other over-the-counter and prescription pain killers. High doses of acetaminophen are known to increase the first of liver problems, including liver failure that may require a transplant.

Overdoses of acetaminophen result in more than 50,000 emergency room visits, 25,000 hospitalizations and over 450 deaths annually, according to data previously provided by the FDA.

This recall is not the first time Qualitest has had manufacturing problems with their generic Vicodin. The drug maker issued another generic Vicodin recall in June 2011, due to a mix-up that resulted in the labels of generic Vicodin and generic Fioricet being swapped. That recall affected four lots of each drug.

Qualitest has indicated that consumers who have recalled generic Vicodin pills from the affected lot should contact the company by calling (800) 444-4011. The lot number can be found on the side of the manufacturer’s bottle. If a consumer is unsure whether their generic Vicodin pills have been affected by the recall they should contact their physician or pharmacist.