REGULATORY INTELLIGENCE·Recall
FDA Initiates Class II Recall of Apipharma's Hemopropin Ointment Over CGMP Deviations from Croatian Facility
Apipharma faces an FDA Class II recall for 4,218 boxes of Hemopropin Ointment, citing Current Good Manufacturing Practice (CGMP) deviations at its Zagreb, Croatia facility. This action, initiated by the firm, highlights critical quality control failures, posing significant supply chain and regulatory compliance challenges for global procurement and regulatory affairs teams sourcing similar topical formulations.
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