Drug product
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
D-0172-2021
Product summary
- Event
- Event 86964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4411 trays
- Official record key
drug-enforcement:D-0172-2021
Official wording
Reason: Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Code information: Batch # 6123760, Exp 02/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent