China NMPA Product Recall - Methotrexate Injection

Sandoz (China) Pharmaceutical Co., Ltd., in coordination with its subsidiary Ebiway Pharmaceutical Co., Ltd., initiated a voluntary global recall of all batches of its Methotrexate Injection packaged in transparent glass ampoules. The National Medical Products Administration (NMPA) published this information on November 25, 2010, following a report from Sandoz. The main issue prompting this extensive recall was the discovery of glass fragments within the product solution across four specific batches of the injection. This significant quality defect presented a potential risk to patient safety. Consequently, Sandoz (China) decided to recall all affected batches sold in the Chinese market, encompassing three strengths: 50mg/5ml, 500 mg/5ml, and 1g/10ml. This action impacted approximately 170,000 boxes of the product. The company's decision to undertake this recall aligns with regulatory frameworks such as the "Drug Recall Management Measures," demonstrating a commitment to protecting patient safety and mitigating potential risks associated with the product's integrity.