D-0849-2018 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
- 9240 bottles
Product Description
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
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 #: 47070021, Exp. 07/19