PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 31, 2019 Initiated: May 31, 2019 #D-1520-2019

Product Description

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

Reason for Recall

cGMP Deviations: Products may have microbial contamination.

Details

Recalling Firm
Geritrex, LLC
Units Affected
8645 bottles
Distribution
U.S.A. Nationwide
Location
Middletown, NY

Frequently Asked Questions

What product 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. Recalled by Geritrex, LLC. Units affected: 8645 bottles.
Why was this product recalled?
cGMP Deviations: Products may have microbial contamination.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1520-2019.