Hydrocodone Bitartrate and Acetaminophen Tablets Recalled for Oversized Tablets

Qualitest Hydrocodone Bitartrate and Acetaminophen Tables are being recalled for oversized tablets, the U.S. Food & Drug Administration (FDA) just announced. Qualitest is a subsidiary of Endo Health Solutions.

The nationwide recall involves one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13. Some tablets from this recalled lot exceed the weight specification and could be super-potent for the ingredients Hydrocodone Bitartrate and Acetaminophen.

Bottles from the affected lot may contain tablets with this higher dosage of acetaminophen. As a result, it is possible that consumers could take more than the intended acetaminophen dose, which could lead to liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than the alcoholic beverages daily.

The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death. Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, including sedation or respiratory depression, particularly in elderly patients and patients with severe kidney or liver impairment or who are also taking interacting medications, such as other sedating medications or certain antidepressants.

No injuries have been reported, to date.

The recalled Hydrocodone Bitartrate and Acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. The recalled lot—lot, C1440512A—was distributed between May 14 and August 3, 2012 to wholesale distributors and retail pharmacies, nationwide.

The lot number is located on the side of the manufacturer’s bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with the numbers “3600” debossed on one side of the tablet and the letter “V” debossed on the other side.

Consumers in possession of the recalled Hydrocodone Bitartrate and Acetaminophen tablets—lot C440512A—are advised by the firm to contact Qualitest, toll-free, at 1.800.444.4011, Monday through Friday, from 8:00 a.m. to 5:00 p.m. Consumers who are unsure if they are in possession of the recalled lot number are advised to consult their pharmacy or health care professional.

Pharmacists and wholesalers are asked to check their inventories for lot C1440512A, to segregate any material from the lot, and to contact MedTurn, toll-free, at 1.800.967.5952 for instructions on product return. Pharmacies that received lot C1440512A will receive a copy of the FDA press release with their recall notification information, which should be posted prominently in the pharmacy area so that patients can be made aware of the recall.