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CHEMICAL & LIFE SCIENCES INTELLIGENCE
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Lorazepam

TRACKED

Benzodiazepine

CAS846-49-1HSN29339900
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
14
Manufacturers monitored
2
Intelligence briefs
1
Active regulatory actions
1
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INTELLIGENCE

Showing 2 of 2 briefs for Lorazepam
REGULATORY INTELLIGENCE·Recall

Hikma Pharmaceuticals' Lorazepam Injection Faces Class II FDA Recall Over Purity Failures

Hikma Pharmaceuticals USA Inc. initiated a Class II recall for 382,775 vials of Lorazepam Injection due to out-of-specification impurities. This voluntary, firm-initiated action, impacting nationwide U.S. distribution, signals critical quality control challenges at their Berkeley Heights, NJ facility. Procurement and regulatory teams must assess immediate supply chain risks and re-evaluate supplier qualification for this essential benzodiazepine.

90-Day Activity
RMRohan Mehta· Senior Supply Chain Intelligence Analyst
2025-08-06
REGULATORY INTELLIGENCE·Warning Letter

FDA Mandates Class II Recall for Major Pharmaceuticals' Sub-Potent Lorazepam: Critical Supply Chain and Regulatory Implications

The Harvard Drug Group LLC dba Major Pharmaceuticals initiated a Class II recall of Lorazepam Tablets, USP, 0.5mg, due to sub-potency and impurity failures. This event highlights critical quality control gaps within the pharmaceutical supply chain, demanding immediate action from procurement and regulatory teams to ensure supply continuity and patient safety for this essential benzodiazepine.

90-Day Activity
LorazepamHSN 3004.90
CMCatherine Morrow· Senior Regulatory Intelligence Analyst
2025-02-26 Warning Letter