Nicotine Polacrilex Lozenge — Class III drug recall D-1558-2014
Terminated recall by Perrigo Holland Inc, reported 2014-09-03, distributed in AR, IL, MN, OH, OR, PA, RI. Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presen
| Recall number | D-1558-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perrigo Holland Inc, Holland, MI, United States |
| Recall initiated | 2014-08-19 |
| Classified | 2014-08-22 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2015-01-13 |
| Distributed | AR, IL, MN, OH, OR, PA, RI |
| Quantity | 366,936 tubes |
| Reason classes | specification failure |
| NDC | 00363-0374-04, 00363-0734-02, 11673-0734-02, 11822-0734-02, 11822-0734-03, 30142-0734-02, 36800-0734-60, 41520-0734, 41520-0734-01, 41520-0734-02, 41520-0734-03, 49035-0734, 49035-0734-01, 49035-0734-03, 49035-0734-04, 59779-0734, 59779-0734-01, 59779-0734-02, 59779-0734-04, 59779-0734-52, 59779-0734-60 |
| Lot numbers | 03/15, 09/14, 2MV1074, 2MV1124, 2MV1142, 2MV1143, 3AV0528, 3FV0421, 3FV0422, 3FV0423, 3FV0520, 3FV0535, 3FV0537, 3FV0575, 3FV0576, 3FV0579, 3FV0615, 3FV0739, 3FV0740, 3FV0742, 3GV0713, 3GV0715 |
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.
Reason for recall
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1558-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.