Bristol-Myers Squibb Company: 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
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Bristol-Myers Squibb Company
- 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 / hazard
- Lack of Assurance of Sterility.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA
- Recall initiated
- 2025-10-21
- Code info
- Lot: 033A23B, Expiry: 4/30/2026
- Product quantity
- 12,778 total vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- New Brunswick
- State
- NJ
- Country
- United States
- Event id
- 97839
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