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AVKARE — Pulaski

Operated by AvKARE · Pulaski, TN
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Intelligence briefs

Regulatory Observation Log

REGULATORY INTELLIGENCERecall2020-06-10

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.

CM
Catherine Morrow
Senior Regulatory Intelligence Analyst
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