FDAFDA · Food and drugs·Recall number D-1243-2014
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
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
- 81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993 (exp 1/15) & 13994 (exp 1/15); 189 Ct Vial Lot # 12H23N (exp 5/14), 12K02N (exp 6/14), 12K06N (exp 10/14), 12K30N (exp 10/14), 12L04N (exp 10/14), 12L04N1 (exp 10/14), 13A08N (exp 10/14), 13B08N (exp 1/15), 13D02N (2/15), 13E01N (exp 3/15), 13E21N (exp 4/15), 13G18N (exp 5/15), 13H06N (exp 5/15), 13H07N (exp 7/15), 13H30N (exp 7/15), 13H30NN (exp 7/15), 13I25N (exp 7/15), 13I26N (exp 8/15) & 13K27N (exp 8/15).
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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