November 25, 2020
The discovery of a losartan tablet in a bottle of hydrocodone bitartrate and acetaminophen tablets has prompted Ascent Pharmaceuticals Inc. to recall the entire lot, according to the November 25, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects hydrocodone bitartrate and acetaminophen tablets, 10 mg/325 mg, 100-count bottles (NDC 31722-943-01), from lot 20070518 (Exp. 6/22). The tablets were manufactured by Ascent Pharmaceuticals for Camber Pharmaceuticals Inc. and distributed throughout the United States.
Ascent Pharmaceuticals voluntarily initiated the recalls on October 26, 2020. The FDA designated them Class II on November 17, 2020. 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 tablets are classified as a Schedule II controlled substance, available with a prescription, to relieve ongoing severe pain. Losartan is used to treat high blood pressure.