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FDAAugust 30, 2017drug

Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1.

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

The hazard

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

What to do

FDA enforcement status: Terminated

Brands named

mid valley pharmaceuticalmidmid valley

UPCs

762558002041

Recall history

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

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