Drug product
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.
D-1246-2014
Product summary
- Event
- Event 67800
- Status
- Terminated
- Classification
- Class III
- Quantity
- 189,900 20 ct Vials, 145,068 81 ct Vials
- Official record key
drug-enforcement:D-1246-2014
Official wording
Reason: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
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)
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
superpotent