D-0847-2018 Class II Terminated
FDA drug recall D-0847-2018 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: 228 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
- 228 bottles
Product Description
RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161
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 #: 47080092, Exp 08/19