D-0128-2023 Class II Terminated
FDA drug recall D-0128-2023 was initiated by Fresenius Kabi USA, LLC on Nov 22, 2022 and is designated Class II. Reason for recall: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. The recall status is terminated (terminated Oct 23, 2023). Affected quantity: 40,025 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 25, 2023
- Initiation Date
- Nov 22, 2022
- Termination Date
- Oct 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,025 vials
Product Description
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), 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 #: 6128399, 6128400, 6128401, exp 04/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0128-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026