Drug recall D-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.
Reason for recall
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Lots and codes
Batch # 6123760, Exp 02/2022
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Quantity
- 4411 trays
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 10, 2020
- Terminated
- August 25, 2022
Related products
- Sensorcaine – drug information
- NDC 63323-467 Sensorcaine · Bupivacaine Hydrochloride 5 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-462 Sensorcaine Mpf · Bupivacaine Hydrochloride 5 mg/mL; Epinephrine Bitartrate… · Fresenius Kabi USA, LLC
- NDC 63323-466 Sensorcaine Mpf · Bupivacaine Hydrochloride 5 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-460 Sensorcaine Mpf · Bupivacaine Hydrochloride 7.5 mg/mL; Epinephrine Bitartrate… · Fresenius Kabi USA, LLC
- NDC 63323-464 Sensorcaine Mpf · Bupivacaine Hydrochloride 2.5 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-465 Sensorcaine · Bupivacaine Hydrochloride 2.5 mg/mL · Fresenius Kabi USA, LLC