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Lamotrigine

TRACKED

Anti-epileptic Agent

CASHSN
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
14
Manufacturers monitored
38
Intelligence briefs
3
Active regulatory actions
₹2,800 Cr
Est. India export value

INTELLIGENCE

Showing 2 of 2 briefs for Lamotrigine
REGULATORY INTELLIGENCE·Recall

AvKARE Lamotrigine Recall: Foreign Substance Contamination Exposes Supply Chain Vulnerabilities

AvKARE's Class III recall of Lamotrigine Tablets, USP, 150 mg, due to desiccant granule contamination, highlights critical quality control lapses. This event, coupled with AvKARE's prior recalls, signals heightened supply chain risks. Procurement and regulatory teams must intensify due diligence for products sourced from or distributed by AvKARE to mitigate potential disruptions.

90-Day Activity
CMCatherine Morrow· Senior Regulatory Intelligence Analyst
2020-06-10 Trending signal
REGULATORY INTELLIGENCE·Warning Letter

FDA Class I Recall: Taro Pharmaceuticals' Lamotrigine Contaminated with Enalapril Maleate

Taro Pharmaceuticals U.S.A., Inc. initiated a Class I recall of Lamotrigine Tablets 100 mg due to enalapril maleate cross-contamination. This critical regulatory action, terminated February 2024, underscores severe quality control failures impacting patient safety and supply chain integrity. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar high-risk events.

90-Day Activity
CMCatherine Morrow· Senior Regulatory Intelligence Analyst
2020-02-19 Warning Letter