Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.
Reported: April 30, 2014 Initiated: February 20, 2014 #D-1245-2014
Product Description
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.
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
- 834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials
- Distribution
- U.S. Nationwide
- Location
- Aiken, SC
Frequently Asked Questions
What product was recalled? ▼
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.. Recalled by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline. Units affected: 834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 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-1245-2014.
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