Reported Apr 30, 2014 · Terminated
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed…
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · 65 Windham Blvd · Aiken, SC · 29805-9384
Is this the product you have?
- Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette
- Distributed ByGlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81
- Count NDC
0135-0511-05189
- Count NDC0135-0511-03
- Lot codes and dates
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)
- Amount recalled
- 146,424 81 Ct. Vials, 105,091 189 Ct Vials
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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