Nicorette Lozenge
FDA Recall NDC 0135-0508
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 0135-0508). 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
834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 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
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.
Batch or Lot Expiration Information
Lot# (20 ct)
Lot# 13444 (exp 05/14), 13486 (exp 06/14), 13547 (exp 06/14), 13619 (exp 06/14), 13675 (exp 07/14), 13833 (exp 11/14), 13921 (exp 11/14), 14008 (exp 1/15), 14150 (exp 4/15), 14195 (exp 4/15), 14260 (exp 7/15), 14286 (exp 7/15), 14379 (exp 9/15), 14428 (exp 9/15), 14463 (exp9/15) & 14507 (exp 10/15); (27 ct) Lot: 14190 (exp 5/15), 14383 (exp 9/15); (81 ct)
Lot# 13374 (exp 4/14), 13392 (exp 4/14), 13445 (exp 5/14), 13487 (exp 6/14), 13559 (exp 6/14), 13575 (exp 7/14), 13594 (exp 7/14), 13678 (exp 8/14), 13737 (exp 9/14), 13797 (exp 10/14), 13817 (exp 11/14), 13891 (exp 11/14), 13996 (exp 1/15), 14104 (exp 3/15), 14127 (exp 4/15), 14131 (exp 4/15), 14137 (exp 4/15), 14142 (exp 4/15), 14149 (exp 4/15), 14186 (exp 5/15), 14198 (exp 5/15), 14259 (exp 7/15), 14354 (exp 9/15), 14355 (exp 9/15), 14438 (exp 10/15), 14455 (exp 10/15) & 14477 (ex[ 10/15); (135 ct)
Lot# 12J08N (exp 8/14), 12K06N (exp 8/14), 12K30N (exp 8/14), 12L18N (exp 8/14), 13B04N (exp 11/14), 13C11N (exp 8/15), 13F18N (exp 5/15), 13H05N (exp 5/15), 13I12N (exp 5/15), 13I28N (exp 5/15), 13K12N (exp 9/15), 13K19N (exp 9/15), 13K20N (exp 9/15).
Affected Packages Involved in this Recall
0135-0508-02Product
0135-0508-03Product
0135-0508-04Product
0135-0509-02Product
0135-0509-03Product
0135-0509-04Product
0125-0508-03Product
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
189,900 20 ct Vials, 145,068 81 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
Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.
Batch or Lot Expiration Information
Lot# (20 ct)
Lot# 14337 (exp 7/15), 14398 (exp 9/15) & 14510 (exp 9/15); (81 ct)
Lot# 14336 (exp 7/15), 14347 (exp 7/15), 14378 (9/15), 14563 (exp 9/15)
Affected Packages Involved in this Recall
0135-0508-02Product
0135-0508-03Product
0135-0508-04Product
0135-0509-02Product
0135-0509-03Product
0135-0509-04Product
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.
