D-1245-2014 Class III Terminated
FDA drug recall D-1245-2014 was initiated by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline on February 20, 2014 and is designated Class III. Reason for recall: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. The recall status is terminated (terminated January 20, 2017). Affected quantity: 834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials.
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
- 834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials
Product Description
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.
Reason for Recall
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Distribution Pattern
U.S. Nationwide
Code Information
(20 ct) Lot #13444 (exp 05/14), 13486 (exp 06/14), 13547 (exp 06/14), 13619 (exp 06/14), 13675 (exp 07/14), 13833 (exp 11/14), 13921 (exp 11/14), 14008 (exp 1/15), 14150 (exp 4/15), 14195 (exp 4/15), 14260 (exp 7/15), 14286 (exp 7/15), 14379 (exp 9/15), 14428 (exp 9/15), 14463 (exp9/15) & 14507 (exp 10/15); (27 ct) Lot: 14190 (exp 5/15), 14383 (exp 9/15); (81 ct) Lot # 13374 (exp 4/14), 13392 (exp 4/14), 13445 (exp 5/14), 13487 (exp 6/14), 13559 (exp 6/14), 13575 (exp 7/14), 13594 (exp 7/14), 13678 (exp 8/14), 13737 (exp 9/14), 13797 (exp 10/14), 13817 (exp 11/14), 13891 (exp 11/14), 13996 (exp 1/15), 14104 (exp 3/15), 14127 (exp 4/15), 14131 (exp 4/15), 14137 (exp 4/15), 14142 (exp 4/15), 14149 (exp 4/15), 14186 (exp 5/15), 14198 (exp 5/15), 14259 (exp 7/15), 14354 (exp 9/15), 14355 (exp 9/15), 14438 (exp 10/15), 14455 (exp 10/15) & 14477 (ex[ 10/15); (135 ct) Lot #12J08N (exp 8/14), 12K06N (exp 8/14), 12K30N (exp 8/14), 12L18N (exp 8/14), 13B04N (exp 11/14), 13C11N (exp 8/15), 13F18N (exp 5/15), 13H05N (exp 5/15), 13I12N (exp 5/15), 13I28N (exp 5/15), 13K12N (exp 9/15), 13K19N (exp 9/15), 13K20N (exp 9/15).