GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline: Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Dist

Is my product affected?

Nicotine polacrilex lozenge, 2 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: 0135-0510-01,108 Count NDC: 0135-0514-03, b

• Brand NICORETTE

Check against the official notice below — it lists the full affected range.

What happened

GlaxoSmithKline Consumer Healthcare is recalling Nicorette nicotine polacrilex lozenges in 2 mg Original Flavor across the United States. The recalled products include 72 count and 108 count cartons that failed manufacturing specifications, resulting in lozenges that are overly thick, overly soft, and either contain too much or too little nicotine. The recall involves multiple lot numbers with varying expiration dates ranging from April 2014 through November 2015, affecting a total of 488,628 units of the 72 count vials and 255,594 units of the 108 count vials.

The source document does not specify what consumers should do if they have purchased this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Details from the source

Reason for recall: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Distribution: U.S. Nationwide Quantity: 488,628 72 Ct Vial, 255,594 108 Ct Vial Lot/code info: Labeled A) 72 Count Vial, Lot # 13404 (exp 4/14),13499 (exp 5/14), 13549 (exp 6/14), 14004 (exp 1/15), 14079 (exp 2/15), 14178 (exp 5/15), 14297 (exp 7/15) & 14425 (exp 9/15); 108 Ct Vial: Lot # 13449 (exp 5/14), 13657 (exp 8/14), 13723 (exp 8/14), 13781 (exp 11/14), 13867 (exp 11/14), 13897 (exp 12/14), 13960 (exp 1/15), 13981 (exp 12/14), 14016 (exp 2/15), 14254 (exp 7/15), 14305 (exp 7/15), 14341 (exp 7/15), 14370 (exp 8/15) & 14465 (exp 11/15). Labeled B) 72 Count Vial, Lot #13417 (exp 5/14), 13570 (exp 6/14), 13974 (exp 1/15), 14089 (exp 2/15), 14225 (exp 5/15), 14269 (exp 7/15), 14311 (exp 7/15) & 14396 (exp 8/15).Labeled C) 108 Ct Vial: Lot #:13656 (exp 8/14), 13753 (exp 9/14).

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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All FDA (Drug enforcement) recalls