FDA recall D-188-2013

Product

Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.

Reason for recall

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-01-18

Report date

2013-03-13

Termination date

2013-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lynwood, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-188-2013