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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Product Detail

Product Description Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
Recall Number D-419-2013
Classification Class III
Code Info Lot # 82507 and 82720.
Product Distributed Qty 27,144 bottles
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 52863
Product Type Drugs
Status Ongoing
Recalling Firm Aaron Industries Inc
City Lynwood
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.