Recalls / Class II
Class IID-0172-2021
Product
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), 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
- Epidural, Retrobulbar
- NDCs
- 63323-460, 63323-465, 63323-467, 63323-464, 63323-466, 63323-462
- FDA application
- NDA018304
- Affected lot / code info
- Batch # 6123760, Exp 02/2022
Why it was recalled
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
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
- 4411 trays
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2020-12-10
- FDA classified
- 2020-12-22
- Posted by FDA
- 2020-12-30
- Terminated
- 2022-08-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0172-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.