FDA recall D-185-2013

Aaron Industries Inc · Class III · drug

Product

Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08

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-185-2013