US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 7, 2018 (8 years ago)

RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
RIJ Pharmaceutical LLC
NDC code
53807-129-16
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0847-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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