Nicotine Lozenge
FDA Recall NDC 59779-734
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nicotine (NDC 59779-734). A significant event, classified as Class III, was initiated on Aug 19, 2014 by Cvs Pharmacy. The reported reason for this action was: "Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
August 2014 Class III Recall: Failed Dissolution Specifications and Failed Tablet Specifications
Recall Number
Class III Terminated
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Aug 19, 2014
Sep 03, 2014
366,936 Tubes
Recall Profile & Regulatory Data
Event ID
69048
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Perrigo Holland Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.
Termination Date
Jan 13, 2015
Product Description
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.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
41520-734-01Product
41520-734-02Product
41520-734-03Product
59779-734-01Product
59779-734-02Product
59779-734-52Product
59779-734-60Product
59779-734-04Product
49035-734-01Product
49035-734-03Product
49035-734-04Product
0363-0734-02Product
0363-0734-04Product
0363-0734-03Product
0363-0734-05Product
30142-734-02Product
11822-0734-3Product
11822-0734-2Product
36800-734-60Product
0363-0374-04Product
11673-734-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
