RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080
Reported: June 20, 2018 Initiated: May 7, 2018 #D-0844-2018
Product Description
RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080
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
- 1505 bottles
- Distribution
- Nationwide in the USA
- Location
- Middletown, NY
Frequently Asked Questions
What product was recalled? ▼
RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080. Recalled by RIJ Pharmaceutical LLC. Units affected: 1505 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-0844-2018.
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