Recalls / Class III
Class IIID-1558-2014
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.
- Brand names
- Careone Nicotine, Nicotine, Equate Nicotine, Nicotine Mini
- Generic name
- Nicotine Polacrilex
- Active ingredient
- Nicotine
- Route
- Oral
- NDCs
- 41520-734, 59779-734, 49035-734, 0363-0734
- FDA application
- ANDA203690
- Affected lot / code info
- 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.
Why it was recalled
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Recalling firm
- Firm
- Perrigo Holland Inc
- Manufacturer
- American Sales Company
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 13295 Reflections Dr, N/A, Holland, Michigan 49424-8220
Distribution
- Quantity
- 366,936 Tubes
- Distribution pattern
- U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.
Timeline
- Recall initiated
- 2014-08-19
- FDA classified
- 2014-08-22
- Posted by FDA
- 2014-09-03
- Terminated
- 2015-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1558-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.