Drug recall D-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.
Reason for recall
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Lots and codes
Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Quantity
- 40,375 vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 22, 2022
- Terminated
- October 23, 2023
Related products
- Sensorcaine – drug information
- NDC 63323-472 Sensorcaine Mpf · Bupivacaine Hydrochloride 7.5 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-461 Sensorcaine · Bupivacaine Hydrochloride 2.5 mg/mL; Epinephrine Bitartrate… · Fresenius Kabi USA, LLC
- NDC 63323-468 Sensorcaine Mpf · Bupivacaine Hydrochloride 2.5 mg/mL; Epinephrine Bitartrate… · Fresenius Kabi USA, LLC
- NDC 63323-463 Sensorcaine · Bupivacaine Hydrochloride 5 mg/mL; Epinephrine Bitartrate… · Fresenius Kabi USA, LLC