FDA recall D-186-2013

Product

Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011

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-186-2013