FDA recall D-0849-2018

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-05-07

Report date

2018-06-20

Termination date

2023-04-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Middletown, NY, United States

Primary source

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