Drug product
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
D-0844-2018
Product summary
- Event
- Event 80053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1505 bottles
- Official record key
drug-enforcement:D-0844-2018
Official wording
Reason: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Code information: Lot #: 47070081, Exp 09/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
out of specification