Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b
Check against the official notice below — it lists the full affected range.
GlaxoSmithKline Consumer Healthcare is recalling Nicorette nicotine polacrilex lozenges, 4 mg, Original Flavor in 72-count and 108-count cartons distributed nationwide. The recall affects approximately 603,696 units of 72-count vials and 191,040 units of 108-count vials due to failed lozenge specifications, including lozenges that are overly thick, overly soft, and contain sub- or superpotent nicotine levels. Multiple lot numbers with expiration dates ranging from April 2014 through October 2015 are included in the recall.
Consumers can identify affected products by checking the lot number and expiration date on their Nicorette lozenge cartons against the specific lot numbers listed in the recall. The source document does not specify a remedy or instructions for affected consumers regarding what action they should take.
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: 603,696 72 Ct Vials, 191,040 108 Ct Vials Lot/code info: Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial, Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial; Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials, Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14), Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial, Lot #13726 (exp 10/14) & 13779 (exp 11/14).
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.