D-0129-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 25, 2023
- Initiation Date
- November 22, 2022
- Termination Date
- October 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,600 vials
Product Description
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.
Reason for Recall
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Distribution Pattern
Nationwide in the USA
Code Information
Batch #: 6128800, exp 12/2023