D-1520-2019 Class II Terminated
FDA drug recall D-1520-2019 was initiated by Geritrex, LLC on May 31, 2019 and is designated Class II. Reason for recall: cGMP Deviations: Products may have microbial contamination. The recall status is terminated (terminated February 2, 2024). Affected quantity: 8645 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- May 31, 2019
- Termination Date
- February 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8645 bottles
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.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 70606, Exp 6/19