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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712. Lot# 81198, 82183, 80797; FP-44-081-03884 Class III 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. 43,464 bottles (3,622 cases) D-188-2013
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. Lot# 71648, 68088; FP-47-041-02535 Class III 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. 5,676 bottles (473 cases) D-187-2013
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 Lot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307 Class III 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. 35,652 bottles (2,971 cases) D-186-2013
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 Lot# 80798; FP-49-081-14870 Class III 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. 6,108 bottles (509 cases) D-185-2013
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