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FDAJune 21, 2019drug

DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

What to do

FDA enforcement status: Terminated

Brands named

pharma naturalpharmapharma natural

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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