D-0845-2018 Class II Terminated
FDA drug recall D-0845-2018 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: 1272 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
- 1272 bottles
Product Description
RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048
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 #: 47080091, Exp. 08/19