REGULATORY INTELLIGENCE·Warning Letter
Hikma Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Due to Critical Labeling Error
Hikma Pharmaceuticals USA Inc. initiated a Class III recall of methylPREDNISolone Sodium Succinate for Injection due to incorrect reconstitution instructions on vial labels. This regulatory event highlights critical quality control vulnerabilities, necessitating immediate review of supply chain integrity and internal labeling protocols for procurement and regulatory affairs teams to mitigate patient safety risks and ensure compliance.
90-Day Activity