Nicorette Lozenge
FDA Recall NDC 0135-0510
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Nicorette (NDC 0135-0510). A significant event, classified as Class III, was initiated on Feb 20, 2014 by Haleon Us Holdings Llc. The reported reason for this action was: "Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent."
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
February 2014 Class III Recall: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Recall Number
Class III Terminated
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Apr 30, 2014
603,696 72 Ct Vials, 191,040 108 Ct Vials
Recall Profile & Regulatory Data
Event ID
67800
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Jan 20, 2017
Product Description
Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.
Batch or Lot Expiration Information
Lot# Labeled A) 72 Ct Vial:
Lot# 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial
Lot# 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial
Lot# 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials
Lot# 13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14)
Lot# 13683 (4/17) & 13862 (11/14), 108 Ct Vial
Lot# 13726 (exp 10/14) & 13779 (exp 11/14).
Affected Packages Involved in this Recall
0135-0510-01Product
0135-0510-06Product
0135-0510-07Product
0135-0511-01Product
0135-0511-06Product
0135-0511-07Product
0135-0515-03Product
30142-862-01Product
0363-0209-01Product
0363-0209-07Product
February 2014 Class III Recall: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Recall Number
Class III Terminated
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Apr 30, 2014
488,628 72 Ct Vial, 255,594 108 Ct Vial
Recall Profile & Regulatory Data
Event ID
67800
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Jan 20, 2017
Product Description
Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.
Batch or Lot Expiration Information
Lot# Labeled A) 72 Count Vial
Lot# 13404 (exp 4/14),13499 (exp 5/14), 13549 (exp 6/14), 14004 (exp 1/15), 14079 (exp 2/15), 14178 (exp 5/15), 14297 (exp 7/15) & 14425 (exp 9/15); 108 Ct Vial:
Lot# 13449 (exp 5/14), 13657 (exp 8/14), 13723 (exp 8/14), 13781 (exp 11/14), 13867 (exp 11/14), 13897 (exp 12/14), 13960 (exp 1/15), 13981 (exp 12/14), 14016 (exp 2/15), 14254 (exp 7/15), 14305 (exp 7/15), 14341 (exp 7/15), 14370 (exp 8/15) & 14465 (exp 11/15). Labeled B) 72 Count Vial
Lot# 13417 (exp 5/14), 13570 (exp 6/14), 13974 (exp 1/15), 14089 (exp 2/15), 14225 (exp 5/15), 14269 (exp 7/15), 14311 (exp 7/15) & 14396 (exp 8/15).Labeled C) 108 Ct Vial:
Lot# :13656 (exp 8/14), 13753 (exp 9/14).
Affected Packages Involved in this Recall
0135-0510-01Product
0135-0510-06Product
0135-0510-07Product
0135-0511-01Product
0135-0511-06Product
0135-0511-07Product
0135-0514-03Product
30142-861-01Product
0363-0208-07Product
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.
