FDA-Drug2018-06-20Class II

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

RIJ Pharmaceutical LLC
Hazard

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Sold states
Nationwide in the USA
Affected count
228 bottles
Manufactured in
40 Commercial Ave, N/A, Middletown, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0847-2018

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