Recalls / Class III

Class IIID-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

Affected lot / code info

Lot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307

Why it was recalled

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.

Recalling firm

Firm

Aaron Industries Inc

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

11865 Alameda St, 11840 S Alameda ST, Lynwood, California 90262-4022

Distribution

Quantity

35,652 bottles (2,971 cases)

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-01-18

FDA classified

2013-03-07

Posted by FDA

2013-03-13

Terminated

2013-11-01

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-186-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.