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.
Reported: April 30, 2014 Initiated: February 20, 2014 #D-1242-2014
Product Description
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.
Reason for Recall
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Details
- Recalling Firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Units Affected
- 147,684 81 Ct Vials, 130564 189 Ct Vials
- Distribution
- U.S. Nationwide
- Location
- Aiken, SC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline. Units affected: 147,684 81 Ct Vials, 130564 189 Ct Vials.
Why was this product recalled? ▼
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 30, 2014. Severity: Low. Recall number: D-1242-2014.
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