Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Label Error on Declared Strength
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
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 CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Reason Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Reason Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Reason Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
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