September 11, 2012 – This week, Qualitest Pharmaceuticals Inc. issued a nationwide recall for one lot of generic Vicodin tablets because they may contain too much of the active ingredients, hydrocodone and acetaminophen, which could result in a potentially lethal overdose for consumers. The problem was discovered after the manufacturer determined that some of the tablets may exceed weight specifications. Just over a year ago, Qualitest issued a similar generic Vicodin recall due to a mix-up that resulted in the drug’s labels being swapped with generic Fioricet labels.
Vicodin Update 1/25/13: An advisory panel from the U.S. Food & Drug Administration (FDA) has voted in favor of moving Vicodin and other hydrocodone combination drugs into the more restrictive schedule II category of controlled substances. The panelists who favored tighter restrictions on the popular class of drugs believe they are pharmacologically similar and carry the same propensity for addiction as other opioid medications that fall into more regulated categories.
What’s the problem?
This generic Vicodin 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
These medications were distributed nationwide between May 14 and August 3, 2012. The pills are pink, capsule-shaped, with the number ‘3600’ marked on one side and the letter ‘V’ debossed on the other. The lot number can be found on the side of the manufacturer’s bottle.
First invented by the German pharmaceutical company Knoll in the 1920’s, Vicodin (hydrocodone and acetaminophen) is a powerful opioid pain reliever that is prescribed more than 100 million times a year in various forms throughout the United States.
The hydrocodone component of Vicodin is an opioid painkiller which belongs to a class of analgesic medications that includes methadone, oxycodone and morphine. All of these drugs are legally controlled substances that have the potential to cause respiratory depression, extreme sedation, and death if taken in excessive quantities.
Acetaminophen is the active ingredient contained in Tylenol and a number of other popular pain relievers. High doses of the substance have been linked to liver problems, including liver failure that may require a transplant. According to the FDA, acetaminophen overdoses result in more than 50,000 emergency room visits, 25,000 hospitalizations, and over 450 deaths each and every year in the United States alone.
Qualitest has stated that consumers who believe they may be in possession of generic Vicodin affected by this recall should contact the company immediately. If you are unsure as to whether your generic Vicodin is included in this recall, you should contact your pharmacist or physician. Talk to your doctor immediately if you begin to experience symptoms of a Vicodin overdose.