Status
Terminated
Drug Enforcement D-0127-2023
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Classification
Class II
Report Date
January 25, 2023
Termination Date
October 23, 2023
Product Information
- Product description
- 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.
- Product quantity
- 40,375 vials
- Reason for recall
- Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Fresenius Kabi USA, LLC
- Address
-
3 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0127-2023
- Event ID
- 91198
- Recall initiation date
- November 22, 2022
- Center classification date
- January 13, 2023
- Code info
- Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024
- More code info
- —