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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 63818
Product Type Drugs
Status Ongoing
Recalling Firm Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
City Huntsville
State AL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-06
Initial Firm Notification of
Consignee or Public
Press Release
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. Lot #: All that begin with the letter "C" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13 Class I Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. 897,379 bottles D-138-2013