FDA recall D-0845-2018

RIJ Pharmaceutical LLC · Class II · drug

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-05-07
Report date: 2018-06-20
Termination date: 2023-04-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Middletown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0845-2018