FDAFDA · Food and drugs·Recall number D-0845-2018
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
Published June 20, 2018 · Recall initiated: May 7, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RIJ Pharmaceutical LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 47080091, Exp. 08/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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