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FDAJune 21, 2019drug

TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.

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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