Diphenhydramine Oral Liquid Alcohol Free recalled over manufacturing violations

Recall date

May 31, 2019

Source

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

Official notice title

Geritrex, LLC recalls Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial…

Recall number

D-1520-2019

FDA classification

Class II

Brand / firm

Geritrex, LLC

Sold / distributed

U.S.A. Nationwide

Why it was recalled

cGMP Deviations: Products may have microbial contamination.

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

What was recalled

Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04