Drug product
Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.
D-1244-2014
Product summary
- Event
- Event 67800
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12,162 Pallets
- Official record key
drug-enforcement:D-1244-2014
Official wording
Reason: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Code information: Lot #12K16W (exp 5/14), 12K27N (exp 6/14), 12K27W (exp 6/14), 12K29N (exp 6/14), 13K20W (exp 6/15), 13K20W1 (exp 6/15) & 13K25N (exp 6/15).
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
superpotent