Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability…
Reason 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…
Reason Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
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