Opdualag (nivolumab and relatlimab-rmbw)

FDA Class II Recall: Bristol-Myers Squibb's Opdualag Faces Sterility Assurance Issues, Impacting 12,778 Vials

Bristol-Myers Squibb Company has initiated a Class II nationwide recall for 12,778 vials of Opdualag (nivolumab and relatlimab-rmbw) injection due to a lack of sterility assurance. This voluntary recall, impacting lot 033A23B, presents significant supply chain and regulatory risks for procurement and regulatory affairs teams. Decision-makers must assess potential supply disruptions and scrutinize supplier quality systems, particularly for sterile injectable oncology treatments, to mitigate patient safety and market access implications.