Sensorcaine Injection, Solution
FDA Recall NDC 63323-461
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Sensorcaine (NDC 63323-461). A significant event, classified as Class II, was initiated on Nov 22, 2022 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Nov 22, 2022
Jan 25, 2023
40,375 vials
Recall Profile & Regulatory Data
Event ID
91198
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Oct 23, 2023
Product Description
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.
Batch or Lot Expiration Information
Batch# : 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024
Affected Packages Involved in this Recall
63323-472-03Product
63323-472-17Product
63323-472-01Product
63323-472-37Product
63323-463-01Product
63323-463-57Product
63323-461-01Product
63323-461-57Product
63323-468-02Product
63323-468-37Product
63323-468-01Product
63323-468-17Product
Class II Terminated
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Nov 22, 2022
Jan 25, 2023
31,600 vials
Recall Profile & Regulatory Data
Event ID
91198
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Oct 23, 2023
Product Description
Sensorcaine-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.
Batch or Lot Expiration Information
Batch# : 6128800, exp 12/2023
Affected Packages Involved in this Recall
63323-472-03Product
63323-472-17Product
63323-472-01Product
63323-472-37Product
63323-463-01Product
63323-463-57Product
63323-461-01Product
63323-461-57Product
63323-468-02Product
63323-468-37Product
63323-468-01Product
63323-468-17Product
Class II Terminated
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Nov 22, 2022
Jan 25, 2023
40,025 vials
Recall Profile & Regulatory Data
Event ID
91198
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Oct 23, 2023
Product Description
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.
Batch or Lot Expiration Information
Batch# : 6128399, 6128400, 6128401, exp 04/2024
Affected Packages Involved in this Recall
63323-472-03Product
63323-472-17Product
63323-472-01Product
63323-472-37Product
63323-463-01Product
63323-463-57Product
63323-461-01Product
63323-461-57Product
63323-468-02Product
63323-468-37Product
63323-468-01Product
63323-468-17Product
Class II Terminated
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Apr 25, 2016
Jun 22, 2016
69225 units
Recall Profile & Regulatory Data
Event ID
73935
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 20, 2016
Product Description
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
Batch or Lot Expiration Information
Lot# : 6111504, Exp 09/2019
Affected Packages Involved in this Recall
63323-472-03Product
63323-472-17Product
63323-472-01Product
63323-472-37Product
63323-463-01Product
63323-463-57Product
63323-461-01Product
63323-461-57Product
63323-468-02Product
63323-468-37Product
63323-468-01Product
63323-468-17Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
