Drug product
Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941
D-0849-2018
Product summary
- Event
- Event 80053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9240 bottles
- Official record key
drug-enforcement:D-0849-2018
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 #: 47070021, Exp. 07/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
out of specification