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
Reported: June 20, 2018 Initiated: May 7, 2018 #D-0847-2018
Product Description
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
Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Details
- Recalling Firm
- RIJ Pharmaceutical LLC
- Units Affected
- 228 bottles
- Distribution
- Nationwide in the USA
- Location
- Middletown, NY
Frequently Asked Questions
What product 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. Recalled by RIJ Pharmaceutical LLC. Units affected: 228 bottles.
Why was this product recalled? ▼
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 20, 2018. Severity: Moderate. Recall number: D-0847-2018.
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