Recalls / Class III

Class IIID-187-2013

Product

Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.

Affected lot / code info

Lot# 71648, 68088; FP-47-041-02535

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

5,676 bottles (473 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-187-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.