Recall D-0097-2026

US Class II Ongoing · initiated 2025-10-21

Recalling firm

Bristol-Myers Squibb Company, NJ

Product

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11

Reason for recall

Lack of Assurance of Sterility.

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