FDA-Drug2018-06-20Class II

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

RIJ Pharmaceutical LLC
Hazard

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Sold states
Nationwide in the USA
Affected count
9240 bottles
Manufactured in
40 Commercial Ave, N/A, Middletown, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0849-2018

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