Drug product
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
D-0129-2023
Product summary
- Event
- Event 91198
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,600 vials
- Official record key
drug-enforcement:D-0129-2023
Official wording
Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Code information: Batch #: 6128800, exp 12/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent