REGULATORY INTELLIGENCE·Recall
Ascend Laboratories' Mycophenolic Acid Recall: Critical Dissolution Failure Impacts Immunosuppressant Supply
Ascend Laboratories, LLC has initiated a nationwide Class II recall for 117,493 bottles of Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, due to failed dissolution specifications. This event, impacting a critical immunosuppressant manufactured by Alkem Laboratories, LTD, India, underscores significant quality control vulnerabilities within the global pharmaceutical supply chain. Procurement and regulatory teams must immediately assess inventory, evaluate alternative suppliers, and reinforce supplier qualification protocols to mitigate patient access risks and ensure compliance.
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