D-1242-2014 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2014
- Initiation Date
- February 20, 2014
- Termination Date
- January 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147,684 81 Ct Vials, 130564 189 Ct Vials
Product Description
Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
Reason for Recall
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Distribution Pattern
U.S. Nationwide
Code Information
81 Ct Vial, Lot # 13727 (exp 8/14), 13816 (exp 10/14), & 13965 (exp 12/14); 189 Ct Vial, Lot # 12H17N (exp 4/14), 12H20N (exp 6/14), 12J16N (exp 6/14), 12K03N (exp 9/14), 12L05N (exp 10/14), 12L07N (exp 9/14), 12L17N (exp 10/14), 13A04N (exp 11/14), 13A23N (exp 11/14), 13C04N (exp 1/15), 13C08N (exp 1/15), 13D17N (exp 11/14), 13D18N (exp 1/15), 13D18N1 (exp 3/15), 13E24N (exp 4/15), 13E28N (exp 4/15), 13G16N (exp 4/15), 13G17N (exp 5/14), 13H02N (exp 5/15), 13H22N (exp 5/15), 13I18N (exp 8/15), 13I20N (exp 5/15), 13J24N (exp 8/15), 13J24N1 (exp 9/15), 13K08N (exp 8/15), 13K11N (exp 9/15), 13L11N (exp 10/15) & 13L11N1 (exp 10/15).