April 24, 2020
Aurobindo Pharma USA Inc. is voluntarily recalling 10 lots of acetaminophen and codeine phosphate tablets because of deviations from Current Good Manufacturing Practice regulations. According to the April 22, 2020, US Food and Drug Administration (FDA) Enforcement Report, the tablets were manufactured in a processing area with a water leak.
The following products, which were distributed throughout the United States, are included in the recall:
- acetaminophen and codeine phosphate tablets, 300 mg/15 mg, 100-count bottles (NDC 13107-058-01) from lots 058180015A (Exp. 7/21), 058180016A (Exp. 7/21), and 05818017B1 (Exp. 9/21);
- acetaminophen and codeine phosphate tablets, 300 mg/30 mg, 100-count bottles (NDC 13107-059-99) from lots 059180023A, 059180024A, and 059180025A (Exp. 5/21); and
- acetaminophen and codeine phosphate tablets, 300 mg/60 mg, 100-count bottles (NDC 13107-060-01) from lots 060180017A, 060180019B1, 060180020A, and 060180021A (Exp. 6/21).
Aurobindo Pharma USA initiated the recall March 18, 2020. On April 13, 2020, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. A remote possibility of serious harm also exists.
Acetaminophen and codeine phosphate tablets are available with a prescription to treat mild to moderate pain.