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
Check against the official notice below — it lists the full affected range.
GlaxoSmithKline Consumer Healthcare is recalling Nicorette Nicotine Polacrilex Lozenges Mini, 2 mg, Original Flavor in 20, 27, 81, and 135 lozenge vials distributed nationwide. The lozenges are being recalled because they failed to meet specifications—some are overly thick and soft, while others contain too much or too little nicotine (superpotent or subpotent).
The recall affects 834,072 vials of the 81-count size, 414,500 vials of the 20-count size, and 9,456 vials of the 135-count size across multiple lot numbers with expiration dates ranging from May 2014 through October 2015. The source record does not specify what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Reason for recall: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Distribution: U.S. Nationwide Quantity: 834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials Lot/code info: (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).
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.