April 24, 2020
HJ Harkins Company Inc., which does business as Pharma Pac, is recalling acetaminophen and codeine phosphate tablets manufactured by Aurobindo, citing deviations from Current Good Manufacturing Practice regulations. The recall was included in the April 22, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects acetaminophen and codeine phosphate tablets, 300 mg/30 mg tablets, from lot ATP12ZT (Exp. 5/21). The tablets were repackaged by HJ Harkins Company in 10-count bottles (NDC 52959-0003-10), 12-count bottles (NDC 52959-0003-12), 14-count bottles (NDC 52959-0003-14), 15-count bottles (NDC 52959-0003-15), 16-count bottles (NDC 52959-0003-16), 20-count bottles (NDC 52959-0003-20), 30-count bottles (NDC 52959-0003-30), and 60-count bottles (NDC 52959-0003-60) and distributed in California and Arizona.
HJ Harkins Company voluntarily initiated the recall April 15, 2020. On April 16, 2020, the FDA designated the recall Class II, communicating use of the affected tablets may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Acetaminophen and codeine phosphate tablets are available with a prescription to treat mild to moderate pain.