Why it was recalled
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
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.
Lot numbers, UPCs & expiration codes
(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)
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-1246-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 20, 2014
- FDA report date
- Apr 30, 2014
- Quantity
- 189,900 20 ct Vials, 145,068 81 ct Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Original FDA data
Every field from FDA enforcement report D-1246-2014, 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
- (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)
- Postal code
- 29805-9384
- Report date
- Apr 30, 2014
- Product type
- Drugs
- Recall number
- D-1246-2014
- Classification
- Class III
- Recalling firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Product quantity
- 189,900 20 ct Vials, 145,068 81 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
- 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.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Feb 20, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2014