Drug product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75
D-0297-2025
Product summary
- Event
- Event 96446
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,765 cassettes
- Official record key
drug-enforcement:D-0297-2025
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot, expiry: Lot 10140303, exp 04/14/2025; Lots 10140867, 10140868, exp 04/24/2025; Lot 10140965, exp 04/28/2025
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility