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FDAJune 21, 2019drug

GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.

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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GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16. — Recall Details · AllClear