D-0846-2018 Class II Terminated
FDA drug recall D-0846-2018 was initiated by RIJ Pharmaceutical LLC on May 7, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. The recall status is terminated (terminated April 7, 2023). Affected quantity: 13380 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 20, 2018
- Initiation Date
- May 7, 2018
- Termination Date
- April 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13380 bottles
Product Description
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164
Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 47080081, 47080093, Exp. 08/19