Acetaminophen Products Recalled

Ultra-Tab Laboratories Inc is voluntarily recalling various acetaminophen products, citing unspecified deviations from Current Good Manufacturing Practice regulations. The recalls are included in the February 16, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were delivered to 3 distributors that may have distributed them to other customers:

• APAP 325-mg tablets (acetaminophen 325 mg), bulk container (NDC 62959-200-00, product code L200L), from bulk lots 18K072 and 19C049;
• APAP 325-mg tablets (acetaminophen 325 mg, pamabrom 25 mg), bulk container (NDC 62959-700-00, product code M700LA), from bulk lots 18K037, 18L093, 18M006, 19A121, 19G044, 19G045, and 19G046;
• Coated APAP 325-mg tablets (acetaminophen 325 mg), bulk container (NDC 62959-202-00, product code L202L), from bulk lots 18K013, 18K014, 18K015, 19A040, 18M076, 19A041, 19H072, 19H073, and 19H074;
• Coated APAP 325-mg, phenyl HCl 5-mg tablets (acetaminophen 325 mg, phenylephrine HCl 5 mg), bulk container (NDC 62959-134-00, product code C134LC), from bulk lots 18K055, 18M081, 19A097, 19B024, 19C054, 19E092, 19G094, and 19J042;
• APAP 500-mg tablets (acetaminophen 500 mg), bulk container (NDC 62959-210-00, product code L210L), from bulk lots 18L120, 19B044, and 19E082;
• APAP 500-mg, phenyl HCl 5-mg tablets (acetaminophen 500 mg, phenylephrine HCl 5 mg), bulk container (NDC 62959-140-00, product code C140L), from bulk lots 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, and 19J051;
• Coated APAP 500-mg tablets (acetaminophen 500 mg), bulk container (NDC 62959-211-00, product code L211L), from bulk lots 18M043, 18M044, 18M045, 19B032, 19B033, 19B034, 19F008, 19F009, and 19F010; and
• Coated APAP 500-mg caplets (acetaminophen 500 mg), bulk container (NDC 62959-206-00, product code L206L), from bulk lot 19B002.

Ultra-Tab Laboratories initiated the recalls January 26, 2022, and the FDA classified them Class II on February 9, 2022. Use of the products under Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Acetaminophen is used to treat mild to moderate pain and reduce fever.