Qualitest Recalls Oversized Pain-Reliever Tablets

En Español

On September 10, 2012 Qualitest pharmaceuticals voluntarily issued a recall of Hydrocodone Bitartrate and Acetaminophen tablets on the retail level. The U.S. Food and Drug Administration reports that users may have gotten more than they bargained for when purchasing these tablets. The affected Hydrocodone Bitartrate and Acetaminophen 10 mg/500 mg tablets contain higher doses than labeled. For patients this could increase the risk of certain adverse reactions such as:

• liver damage or liver toxicity
• respiratory depression
• an increase or magnification of side effects
• death

Patients with pre-existing complications, especially liver disease, kidney damage, and anyone who drinks frequently or is elderly, are most at risk for these side effects and should not attempt to use any recalled products.

Hydrocodone Bitartrate and Acetaminophen 10 mg/ 500 mg tablets shown above.

Which Tablets are Involved in the Recall?

The nationwide recall involves Hydrocodone Bitartrate and Acetaminophen 10 mg/500 mg tablets 100 count from Lot Number C1440512A. The product comes in the form of pink, capsule-shaped tablets inscribed with “3600” on one side and a “V” on the reverse side. The prescription is labeled with an expiration date of December 2013 and had been distributed starting on May 14, 2012 and ending on Aug. 3, 2012.

What Should I Do if I have a Recalled Product?

Consumers who possess any recalled products should discontinue use of the medication immediately and call Qualitest at 1-800-444-4011 for further instructions on returning the product. Pharmacies or retailers with Hydrocodone Bitartrate and Acetaminophen should check their inventory to prevent further distribution of the recalled tablets.

No serious side effects related to the recall have been reported. If you have experienced an adverse reaction due to this product, contact Qualitest by calling 1-800-444-4011 or report the information to the FDA’s MedWatch Adverse Event Reporting program. Visit the U.S. Food and Drug Administration site here for more details on how to contact the MedWatch Program or for more information on the recall.