Pain Medication Recalled

Ascent Pharmaceuticals Inc is recalling 9744 bottles of hydrocodone bitartrate and acetaminophen tablets due to a product mix-up. The recall is included in the December 15, 2021, US Food and Drug Administration (FDA) Enforcement Report, which contains no details on the mix-up that prompted the recall.

The recall affects 100-count bottles of hydrocodone bitartrate and acetaminophen tablets, 10 mg/325 mg (NDC 31722-943-01), from lot 21070817 (Exp. 6/23). The tablets were manufactured by Ascent Pharmaceuticals, Central Islip, NY, for Camber Pharmaceuticals Inc, Piscataway, NJ, and were distributed throughout the United States.

Ascent Pharmaceuticals voluntarily initiated the recall November 19, 2021. The FDA designated the recall Class II on December 7, 2021. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Hydrocodone bitartrate and acetaminophen is a prescription opioid used to treat moderate to severe pain.