REGULATORY INTELLIGENCE·Warning Letter
American Regent Initiates Class II Recall of Venofer (Iron Sucrose) Injection Over Glass Delamination Risk
American Regent, Inc. has initiated a Class II recall for Venofer (iron sucrose) Injection due to potential glass delamination, leading to particulate matter. This event, D-0080-2025, impacts nationwide supply in the USA, demanding immediate attention from procurement, regulatory, and supply chain leaders to assess inventory, patient safety, and future supply resilience for critical parenteral iron therapies.
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