GlaxoSmithKline Recalls Nicorette Lozenge and NicoDerm CQ Combination Pack
GlaxoSmithKline is recalling a specific lot of Nicorette Lozenge and NicoDerm CQ combination packs because the lozenges failed quality specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a manufacturing specification failure rather than a safety hazard like contamination or mislabeling.
Plain-English summary
GlaxoSmithKline Consumer Healthcare is recalling 150 cases of the Nicorette Lozenge and NicoDerm CQ nicotine polacrilex system. The affected product is the OTC combination pack containing 189 2mg Mint Flavored Lozenges and 21 31 mg Patches. The recall is limited to Lot #13L05N with an expiration date of 8/15.
The recall was initiated because the lozenges failed to meet required specifications. Specifically, the lozenges were found to be overly thick, overly soft, and sub and superpotent. The product was distributed nationwide in the United States.
Consumers who have this specific product should stop using it and contact GlaxoSmithKline for further instructions.
The recalled product
- Product
- Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.
- Hazard
- Affected units
- 150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #13L05N
- Expiry: 8/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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- ModerateGlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications
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- ModerateGlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications
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