D-0844-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 20, 2018
- Initiation Date
- May 7, 2018
- Termination Date
- April 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1505 bottles
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 47070081, Exp 09/18