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
D-1520-2019
Product summary
- Firm
- Geritrex, LLC
- Event
- Event 83200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8645 bottles
- Official record key
drug-enforcement:D-1520-2019
Official wording
Reason: cGMP Deviations: Products may have microbial contamination.
Code information: Lot #: 70606, Exp 6/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Microbial contamination
microbial contamination