Recalls / Class III

Class IIID-1242-2014

Product

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.

Affected lot / code info

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).

Why it was recalled

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

Recalling firm

Firm

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

65 Windham Blvd, N/A, Aiken, South Carolina 29805-9384

Distribution

Quantity

147,684 81 Ct Vials, 130564 189 Ct Vials

Distribution pattern

U.S. Nationwide

Timeline

Recall initiated

2014-02-20

FDA classified

2014-04-18

Posted by FDA

2014-04-30

Terminated

2017-01-20

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1242-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.