Recalls / Class II
Class IID-0127-2023
Product
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.
- Brand name
- Sensorcaine
- Generic name
- Bupivacaine Hydrochloride And Epinephrine Bitartrate
- Active ingredients
- Bupivacaine Hydrochloride, Epinephrine Bitartrate
- Route
- Infiltration, Perineural
- NDCs
- 63323-461, 63323-472, 63323-463, 63323-468
- FDA application
- ANDA070967
- Affected lot / code info
- Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024
Why it was recalled
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 40,375 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-11-22
- FDA classified
- 2023-01-13
- Posted by FDA
- 2023-01-25
- Terminated
- 2023-10-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0127-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.