FDA-Drug2019-07-31Class II

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

Geritrex, LLC
Hazard

cGMP Deviations: Products may have microbial contamination.

Sold states
U.S.A. Nationwide
Affected count
8645 bottles
Manufactured in
40 Commercial Ave, N/A, Middletown, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1520-2019

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