FDAFDA · Food and drugs·Recall number D-1238-2014
Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01.
Published April 30, 2014 · Recall initiated: February 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Distributor
- U.S. Nationwide
- Lot
- Labeled A) 72 Ct Vial: Lot #13468 (exp 4/14), 13618 (exp 6/14) & 14105 (exp 2/15); 81 Ct- Vial, Lot #13815 (exp 10/14), 13864 (exp 11/14) & 13941 (exp 12/14); 108 Ct- Vial, Lot # 13574 (exp 7/14). Labeled B) 72 Ct Vial, Lot #13573 (exp 6/14) & 14257 (exp 7/15). Labeled C) 72 Ct Vial: Lot # 13875 (exp 5/14), 13642 (exp 7/14), 13770 (exp 8/14) & 13875 (exp 11/14).
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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