Recalls / Class II
Class IID-0845-2018
Product
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
- Affected lot / code info
- Lot #: 47080091, Exp. 08/19
Why it was recalled
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recalling firm
- Firm
- RIJ Pharmaceutical LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 40 Commercial Ave, N/A, Middletown, New York 10941-1444
Distribution
- Quantity
- 1272 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-05-07
- FDA classified
- 2018-06-08
- Posted by FDA
- 2018-06-20
- Terminated
- 2023-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0845-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.