Drug product
Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.
D-1247-2014
Product summary
- Event
- Event 67800
- Status
- Terminated
- Classification
- Class III
- Quantity
- 150 cases
- Official record key
drug-enforcement:D-1247-2014
Official wording
Reason: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Code information: Lot #13L05N, Expiry: 8/15
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
superpotent