Cold Tablets Recalled

Unspecified deviations from Current Good Manufacturing Practice regulations have prompted Ultra-Tab Laboratories Inc to recall millions of cold tablets sold in bulk containers, according to the February 16, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following products, which were delivered to 3 distributors that may have further distributed the tablets:

• 3-component cold tabs (acetaminophen 325 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg), bulk container (NDC 62959-106-00, product codes C106L and C106LA), from bulk lots 18J080, 18L029, 19A103, 19B063, 19D019, 19F065, 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, and 19J027; and
• 4-component cold tabs (acetaminophen 325 mg, guaifenesin 200 mg, dextromethorphan HBr 15 mg, phenylephrine HCl 5 mg), bulk container (NDC 62959-107-00, product codes C107L, C107LB, and C107LA), from bulk lots 18G085, 19B061, 19F066, 19J068, 18J051, 18M079, 18M080, 19B017, 19B018, 19C001, 19C081, 19D056, 19D057, and 19F067.

Ultra-Tab Laboratories voluntarily initiated the recall January 26, 2022. On February 9, 2022, the FDA designated the recall Class II. 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.

Combination medications featuring acetaminophen, guaifenesin, and phenylephrine are used to ease cold and allergy symptoms such as aches, fever, and congestion. Dextromethorphan is a cough suppressant.