Drug 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
D-0097-2026
Product summary
- Event
- Event 97839
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12,778 total vials
- Official record key
drug-enforcement:D-0097-2026
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot: 033A23B, Expiry: 4/30/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility