Class III · Low risk
Nicotine Transdermal System Patch
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Nicotine polacrilex lozenge
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDCs
0135-0511-03
0135-0511-05
Compare with the code on your package — it is the most precise check available.
Drug: Nicotine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Nicorette nicotine polacrilex NDC 00135-0511 |
NICOTINE 4 mg/1 | Lozenge Oral |
Haleon US Holdings LLC | OTC |
- Recalling firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1243-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nicotine recalls
See all
Class III · Low risk
Nicotine Gum
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 current approved drug labeling.
Class III · Low risk
Nicotine Polacrilex Lozenge
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Class III · Low risk
Nicorette Lozenge and NicoDerm CQ
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette (nicotine polacrilex)
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Other recalls by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
All 2014 recalls
Class III · Low risk
Nicorette Lozenge and NicoDerm CQ
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette (nicotine polacrilex)
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette (nicotine polacrilex)
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette Lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
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