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.