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RIJ Pharmaceutical LLC recalls RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMME

Recalled June 20, 2018 · FDA recall D-0847-2018 · RIJ Pharmaceutical

Hazard
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. · FDA Class II
Units
228 bottles
Sold at
Nationwide in the USA

Description

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

Product
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
Manufacturer(s)
RIJ Pharmaceutical LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

RIJ Pharmaceutical LLC recalls RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMME | RecallWatchUSA