FDA Recall D-138-2013

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals · Huntsville, AL

Class I — life-threatening Terminated 3148 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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 / code: 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

Quantity: 897,379 bottles

Reason for recall

Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.

Recall record

Recall number: D-138-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide and Puerto Rico
Recall initiated: 2012-12-06
Classified by FDA Center: 2013-01-30
FDA published: 2013-02-06
Terminated: 2021-07-20
Recalling firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Firm location: Huntsville, AL

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