REGULATORY INTELLIGENCE·Warning Letter
Novocol Pharmaceutical's OraVerse Recall: Phentolamine Mesylate Supply at Risk Due to Defective Cartridges
Novocol Pharmaceutical of Canada, Inc. has initiated a Class II recall for 1,636 cartons of OraVerse (Phentolamine Mesylate) Injection due to defective, cracked cartridges. This voluntary, nationwide U.S. recall, impacting lot D05004E, signals critical quality control deficiencies. Procurement and regulatory teams must assess supply chain resilience for Phentolamine Mesylate, as product integrity failures carry significant patient safety and market availability risks.
90-Day Activity