Recalls / Class III
Class IIID-1241-2014
Product
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.
- Brand name
- Nicorette
- Generic name
- Nicotine Polacrilex
- Active ingredient
- Nicotine
- Route
- Oral
- NDCs
- 0135-0510, 0135-0511
- FDA application
- NDA021330
- Affected lot / code info
- 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).
Why it was recalled
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Recalling firm
- Firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 65 Windham Blvd, N/A, Aiken, South Carolina 29805-9384
Distribution
- Quantity
- 488,628 72 Ct Vial, 255,594 108 Ct Vial
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2014-02-20
- FDA classified
- 2014-04-18
- Posted by FDA
- 2014-04-30
- Terminated
- 2017-01-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1241-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.