Doctor Manzanilla Cough & Cold Syrup recalled over manufacturing violations

Recall date

August 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mid Valley Pharmaceutical recalls Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg…

Recall number

D-1136-2017

FDA classification

Class II

Brand / firm

Mid Valley Pharmaceutical

Sold / distributed

TX

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Doctor Manzanilla Cough & Cold (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 00316 1.