Anxiety Medication Recalled

ANI Pharmaceuticals Inc is recalling more than 500,000 bottles of alprazolam tablets because of deviations from Current Good Manufacturing Practice regulations, according to the February 23, 2022, US Food and Drug Administration (FDA) Enforcement Report. The report did not provide specifics on the deviations.

The recall affects the following products, which were distributed throughout the United States by Par Pharmaceutical, Chestnut Ridge, NY:

• alprazolam tablets, .25 mg, packaged in 100-count bottles (NDC 67253-900-10), from lots 19C003A (Exp. 3/22) and 19G002A (Exp. 7/22);
• alprazolam tablets, .25 mg, packaged in 500-count bottles (NDC 67253-900-50), from lot 19C004B (Exp. 3/22);
• alprazolam tablets, .25 mg, packaged in 1000-count bottles (NDC 67253-900-11), from lot 19C048C (Exp. 3/22);
• alprazolam tablets, .5 mg, packaged in 100-count bottles (NDC 67253-901-10), from lots 19B029A (Exp. 2/22) and 19D021A (Exp. 4/22);
• alprazolam tablets, .5 mg, packaged in 500-count bottles (NDC 67253-901-50), from lots 19A087B, 19A088B, 19A089B, and 19A090B (Exp. 2/22), and 19A086B, 19A091B, and 19B019B (Exp. 2/22);
• alprazolam tablets, .5 mg, packaged in 1000-count bottles (NDC 67253-901-11), from lots 19B020C, 19B021C, 19B027C, and 19B028C (Exp. 2/22), 19E056C and 19E057C (Exp. 5/22), 19E059C (Exp. 6/22), and 19G072C (Exp. 7/22);
• alprazolam tablets, 1.0 mg, packaged in 100-count bottles (NDC 67253-902-10), from lots 19B081A (Exp. 2/22), 19E088A and 19E089A (Exp. 5/22);
• alprazolam tablets, 1.0 mg, packaged in 500-count bottles (NDC 67253-902-50), from lots 19A102B (Exp. 2/22), 19D067B and 19D068B (Exp. 4/22), and 19D070C (Exp. 5/22);
• alprazolam tablets, 1.0 mg, packaged in 1000-count bottles (NDC 67253-902-11), from lots 19F045C and 19F046C (Exp. 6/22), 19B082C and 19B083C (Exp. 3/22), and 19D069C (Exp. 5/22);
• alprazolam tablets, 2.0 mg, packaged in 100-count bottles (NDC 67253-903-10), from lots 19C002A (Exp. 3/22), and 19E012A and 19E013A (Exp. 5/22); and
• alprazolam tablets, 2.0 mg, packaged in 500-count bottles (NDC 67253-903-50), from lots 19C100B (Exp. 4/22), and 19E001B and 19E002B (Exp. 5/22).

ANI Pharmaceuticals voluntarily initiated the recall February 15, 2022. The FDA designated the recall Class II on February 17, 2022. 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.

Alprazolam is a prescription benzodiazepine used to treat patients with anxiety and panic disorders.