Nicotine Polacrilex Lozenge recall: Failed Dissolution
Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02.
Why was Nicotine Polacrilex Lozenge recalled?
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Cartons of 27 ct Tubes: Lot #: 2MV1074, Expiry: 09/14; Lot #: 2MV1124, Expiry: 09/14; Lot #: 2MV1142, Expiry: 09/14; Lot #: 2MV1143, Expiry: 09/14; Lot #: 3AV0528, Expiry: 09/14; Lot #: 3FV0575, Expiry: 09/14; Lot #: 3FV0535, Expiry: 03/15; Lot #: 3FV0537, Expiry: 03/15; Lot #: 3FV0576, Expiry: 03/15; Lot #: 3FV0579, Expiry: 03/15; Lot #: 3FV0615, Expiry: 03/15; Lot #: 3FV0739, Expiry: 03/15; Lot #: 3FV0742, Expiry: 03/15, Lot #: 3GV0713, Expiry: 03/15; Lot #: 3GV0715, Expiry: 03/15, Lot #: 3FV0421, Expiry: 03/15, Lot #: 3FV0422, Expiry: 03/15; Lot #: 3FV0423, Expiry: 03/15; Lot #: 3FV0740, Expiry: 03/15. 20 Ct Stretchcard: Lot #: 3FV0520, Expiry: 03/15.
- Product
- Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02.
- Recalling firm
- Perrigo Holland Inc
- Quantity
- 366,936 Tubes
- Distribution
- U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.
- Recall date
- September 3, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)