Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Nicotine polacrilex lozenge, 4 mg, Cherry 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: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability…
Reason Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the…
Reason Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
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