Recalls / Class III

Class IIID-185-2013

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

Affected lot / code info

Lot# 80798; FP-49-081-14870,

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

6,108 bottles (509 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-185-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.