Why it was recalled
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Product description
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
Lot numbers, UPCs & expiration codes
81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993 (exp 1/15) & 13994 (exp 1/15); 189 Ct Vial Lot # 12H23N (exp 5/14), 12K02N (exp 6/14), 12K06N (exp 10/14), 12K30N (exp 10/14), 12L04N (exp 10/14), 12L04N1 (exp 10/14), 13A08N (exp 10/14), 13B08N (exp 1/15), 13D02N (2/15), 13E01N (exp 3/15), 13E21N (exp 4/15), 13G18N (exp 5/15), 13H06N (exp 5/15), 13H07N (exp 7/15), 13H30N (exp 7/15), 13H30NN (exp 7/15), 13I25N (exp 7/15), 13I26N (exp 8/15) & 13K27N (exp 8/15).
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-1243-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 20, 2014
- FDA report date
- Apr 30, 2014
- Quantity
- 146,424 81 Ct. Vials, 105,091 189 Ct Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Original FDA data
Every field from FDA enforcement report D-1243-2014, 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
- 81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993 (exp 1/15) & 13994 (exp 1/15); 189 Ct Vial Lot # 12H23N (exp 5/14), 12K02N (exp 6/14), 12K06N (exp 10/14), 12K30N (exp 10/14), 12L04N (exp 10/14), 12L04N1 (exp 10/14), 13A08N (exp 10/14), 13B08N (exp 1/15), 13D02N (2/15), 13E01N (exp 3/15), 13E21N (exp 4/15), 13G18N (exp 5/15), 13H06N (exp 5/15), 13H07N (exp 7/15), 13H30N (exp 7/15), 13H30NN (exp 7/15), 13I25N (exp 7/15), 13I26N (exp 8/15) & 13K27N (exp 8/15).
- Postal code
- 29805-9384
- Report date
- Apr 30, 2014
- Product type
- Drugs
- Recall number
- D-1243-2014
- Classification
- Class III
- Recalling firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Product quantity
- 146,424 81 Ct. Vials, 105,091 189 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, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Feb 20, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2014