Drug product
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
D-0127-2023
Product summary
- Event
- Event 91198
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40,375 vials
- Official record key
drug-enforcement:D-0127-2023
Official wording
Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Code information: Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent