D-1238-2014 Class III Terminated
FDA drug recall D-1238-2014 was initiated by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline on February 20, 2014 and is designated Class III. Reason for recall: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. The recall status is terminated (terminated January 20, 2017). Affected quantity: 109,848 72 Ct Vials, 61,332 81 Ct Vials, 16,218 108 Ct Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2014
- Initiation Date
- February 20, 2014
- Termination Date
- January 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109,848 72 Ct Vials, 61,332 81 Ct Vials, 16,218 108 Ct Vials
Product Description
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.
Reason for Recall
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Distribution Pattern
U.S. Nationwide
Code Information
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).