FDA recall D-1097-2014

Product

Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.

Reason for recall

Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-02-04

Report date

2014-03-12

Termination date

2014-10-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lynwood, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1097-2014