FDA recall D-1520-2019

Geritrex, LLC · Class II · drug

Product

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.

Distribution

U.S.A. Nationwide

Key facts

Status: Terminated
Initiation date: 2019-05-31
Report date: 2019-07-31
Termination date: 2024-02-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Middletown, NY, United States

Primary source

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