Class III · Low risk Terminated
Lamotrigine Tablets
Reason Labeling: Label Error on Declared Strength
Lamotrigine Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
What was recalled
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
- Recalling firm
- AVKARE Inc.
- NDC code
- 42291-368-60
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1289-2020
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.
Other Lamotrigine recalls
See all
Class II · Moderate risk Terminated
Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Lamotrigine Tablets
Reason Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Class I · High risk Terminated
Lamotrigine Tablets
Reason Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class II · Moderate risk Terminated
Lamotrigine Extended-Release Tablets
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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