Why it was recalled
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Product description
Nicotine polacrilex lozenge, 4 mg, Cherry 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: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.
Lot numbers, UPCs & expiration codes
Labeled A) 72 Ct Vial, Lot # 13481 (exp 5/14), 13674 (exp 5/14), 14056 (exp 2/15), 14092 (exp 3/15), 14258 (exp 7/15), 14450 (exp 10/15); 81 Ct Vial, Lot # 13855 (exp 1/15), 13927 (exp 10/14) & 14093 (exp 3/15); 108 Ct Vial, Lot # 13643 (exp 8/14) & 13992 (exp 12/14). Labeled B) 72 Ct Vial, Lot # 14041 (exp 2/15), 14117 (exp 2/15) & 14268 (exp 4/15); Labeled C) 72 Ct Vial Lot #13671 (exp 8/14) & 13890 (exp 11/14).
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1239-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 20, 2014
- FDA report date
- Apr 30, 2014
- Quantity
- 304,332 72 Ct Vials, 85,080 81 Ct Vials 22,992 108 Ct Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Original FDA data
Every field from FDA enforcement report D-1239-2014, exactly as published.
Show all FDA fields
- City
- Aiken
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 67800
- Address
- 65 Windham Blvd
- Code information
- Labeled A) 72 Ct Vial, Lot # 13481 (exp 5/14), 13674 (exp 5/14), 14056 (exp 2/15), 14092 (exp 3/15), 14258 (exp 7/15), 14450 (exp 10/15); 81 Ct Vial, Lot # 13855 (exp 1/15), 13927 (exp 10/14) & 14093 (exp 3/15); 108 Ct Vial, Lot # 13643 (exp 8/14) & 13992 (exp 12/14). Labeled B) 72 Ct Vial, Lot # 14041 (exp 2/15), 14117 (exp 2/15) & 14268 (exp 4/15); Labeled C) 72 Ct Vial Lot #13671 (exp 8/14) & 13890 (exp 11/14).
- Postal code
- 29805-9384
- Report date
- Apr 30, 2014
- Product type
- Drugs
- Recall number
- D-1239-2014
- Classification
- Class III
- Recalling firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Product quantity
- 304,332 72 Ct Vials, 85,080 81 Ct Vials 22,992 108 Ct Vials
- Termination date
- Jan 20, 2017
- Reason for recall
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nicotine polacrilex lozenge, 4 mg, Cherry 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: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Feb 20, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2014