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Recall Enforment Report D-0128-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Fresenius Kabi USA, LLC, originally initiated on 11-22-2022 for the product 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. The product was recalled due to subpotent drug: testing results below the defined limit for the epinephrine portion of this product.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0128-202311-22-202201-25-2023Class II40,025 vialsSensorcaine (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.Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.Terminated
D-0127-202311-22-202201-25-2023Class II40,375 vialsSensorcaine (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.Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.Terminated
D-0129-202311-22-202201-25-2023Class II31,600 vialsSensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
63323-461Sensorcaine App Pharmaceuticals, Llc
63323-461Sensorcaine Bupivacaine Hydrochloride And Epinephrine BitartrateInjection, SolutionInfiltration; PerineuralFresenius Kabi Usa, LlcHuman Prescription Drug
63323-463Sensorcaine App Pharmaceuticals, Llc
63323-463Sensorcaine Bupivacaine Hydrochloride And Epinephrine BitartrateInjection, SolutionPerineuralFresenius Kabi Usa, LlcHuman Prescription Drug
63323-468Sensorcaine MPFApp Pharmaceuticals, Llc
63323-468Sensorcaine MPFBupivacaine Hydrochloride And Epinephrine BitartrateInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralFresenius Kabi Usa, LlcHuman Prescription Drug
63323-468Sensorcaine MPFBupivacaine Hydrochloride And Epinephrine BitartrateInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralFresenius Kabi Usa, LlcHuman Prescription Drug
63323-472Sensorcaine MPFApp Pharmaceuticals, Llc
63323-472Sensorcaine MPFApp Pharmaceuticals, Llc
63323-472Sensorcaine MPFBupivacaine HydrochlorideInjection, SolutionEpidural; RetrobulbarFresenius Kabi Usa, LlcHuman Prescription Drug