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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description 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.
Recall Number D-187-2013
Classification Class III
Code Info Lot# 71648, 68088; FP-47-041-02535
Product Distributed Qty 5,676 bottles (473 cases)
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.

Event Detail

Event Id 64298
Product Type Drugs
Status Ongoing
Recalling Firm Aaron Industries Inc
City Lynwood
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-18
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide