MYLAN PHARMACEUTICALS INC — Class II: Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton
Mylan Pharmaceuticals Inc. has initiated a Class II recall for Mycophenolate Mofetil for Injection USP, 500 mg/Vial, due to the presence of precipitate in the product. The recall affects the 4-vial carton configuration (NDC 67457-386-00) and is currently classified as ongoing.
This recall affects Mylan Pharmaceuticals Inc., Mylan Institutional LLC, and healthcare providers or facilities utilizing this specific injectable immunosuppressant. It impacts personnel in sterile manufacturing, quality control, and hospital pharmacy procurement.
The presence of precipitate in an injectable medication presents a significant safety risk, potentially leading to vascular complications or reduced therapeutic efficacy. For regulatory professionals, this suggests a potential breakdown in manufacturing controls or product stability, which may necessitate a thorough review of the sterile manufacturing process and supply chain oversight for products manufactured in international facilities.
QA and supply chain teams should immediately identify and quarantine affected lots of NDC 67457-386-00. Manufacturing and quality units should initiate an investigation into the root cause of the precipitate, focusing on sterile fill-finish stability and container-closure integrity.
Class II. Reason: Presence of precipitate. Product: Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.. Firm: MYLAN PHARMACEUTICALS INC (Morgantown WV United States). Status: Ongoing.
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