Sensorcaine Injection, Solution
FDA Recall NDC 63323-460
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sensorcaine (NDC 63323-460). A significant event, classified as Class II, was initiated on Dec 10, 2020 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Subpotent Drug: Low out-of-specification assay results for the epinephrine component."
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: Low out-of-specification assay results for the epinephrine component.
Dec 10, 2020
Dec 30, 2020
4411 trays
Recall Profile & Regulatory Data
Event ID
86964
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
Aug 25, 2022
Product Description
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.
Batch or Lot Expiration Information
Batch# 6123760, Exp 02/2022
Affected Packages Involved in this Recall
63323-465-01Product
63323-465-57Product
63323-467-01Product
63323-467-57Product
63323-460-01Product
63323-460-37Product
63323-464-02Product
63323-464-37Product
63323-464-03Product
63323-464-31Product
63323-466-01Product
63323-466-37Product
63323-466-02Product
63323-466-31Product
63323-462-04Product
63323-462-17Product
63323-462-01Product
63323-462-37Product
63323-462-02Product
63323-462-31Product
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.
