Xylocaine Injection, Solution
FDA Recall NDC 63323-481
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Xylocaine (NDC 63323-481). A significant event, classified as Class II, was initiated on Apr 13, 2022 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "cGMP deviations: Temperature abuse"
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
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
76 trays/25 vials per tray
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 25-count box (NDC 63323-482-57), Rx only, MFG: Fresenius Kabi USA LLC
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
63323-492-04Product
63323-492-27Product
63323-492-09Product
63323-492-57Product
63323-492-07Product
63323-492-37Product
63323-492-03Product
63323-492-31Product
63323-491-01Product
63323-491-57Product
63323-495-09Product
63323-495-27Product
63323-495-04Product
63323-495-07Product
63323-485-01Product
63323-485-27Product
63323-485-03Product
63323-485-57Product
63323-486-01Product
63323-486-17Product
63323-486-02Product
63323-486-27Product
63323-486-05Product
63323-486-57Product
63323-484-57Product
63323-489-02Product
63323-489-27Product
63323-489-03Product
63323-489-21Product
63323-489-01Product
63323-489-17Product
63323-488-07Product
63323-488-37Product
63323-488-03Product
63323-488-31Product
63323-488-01Product
63323-488-17Product
63323-481-01Product
63323-481-57Product
63323-483-03Product
63323-483-27Product
63323-483-01Product
63323-483-57Product
63323-482-01Product
63323-482-17Product
63323-482-03Product
63323-482-27Product
63323-482-05Product
63323-482-57Product
63323-487-01Product
63323-487-17Product
63323-487-07Product
63323-487-37Product
63323-487-03Product
63323-487-31Product
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
33 trays/25 vials per tray
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
63323-492-04Product
63323-492-27Product
63323-492-09Product
63323-492-57Product
63323-492-07Product
63323-492-37Product
63323-492-03Product
63323-492-31Product
63323-491-01Product
63323-491-57Product
63323-495-09Product
63323-495-27Product
63323-495-04Product
63323-495-07Product
63323-485-01Product
63323-485-27Product
63323-485-03Product
63323-485-57Product
63323-486-01Product
63323-486-17Product
63323-486-02Product
63323-486-27Product
63323-486-05Product
63323-486-57Product
63323-484-57Product
63323-489-02Product
63323-489-27Product
63323-489-03Product
63323-489-21Product
63323-489-01Product
63323-489-17Product
63323-488-07Product
63323-488-37Product
63323-488-03Product
63323-488-31Product
63323-488-01Product
63323-488-17Product
63323-481-01Product
63323-481-57Product
63323-483-03Product
63323-483-27Product
63323-483-01Product
63323-483-57Product
63323-482-01Product
63323-482-17Product
63323-482-03Product
63323-482-27Product
63323-482-05Product
63323-482-57Product
63323-487-01Product
63323-487-17Product
63323-487-07Product
63323-487-37Product
63323-487-03Product
63323-487-31Product
June 2021 Class II Recall: Low out of specification results for epinephrine assay.
Recall Number
Class II Terminated
Low out of specification results for epinephrine assay.
Jun 25, 2021
Jul 14, 2021
234,800 vials
Recall Profile & Regulatory Data
Event ID
88194
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Dec 28, 2022
Product Description
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
Batch or Lot Expiration Information
Batch# Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
Affected Packages Involved in this Recall
63323-492-04Product
63323-492-27Product
63323-492-09Product
63323-492-57Product
63323-492-07Product
63323-492-37Product
63323-492-03Product
63323-492-31Product
63323-491-01Product
63323-491-57Product
63323-495-09Product
63323-495-27Product
63323-495-04Product
63323-495-07Product
63323-485-01Product
63323-485-27Product
63323-485-03Product
63323-485-57Product
63323-486-01Product
63323-486-17Product
63323-486-02Product
63323-486-27Product
63323-486-05Product
63323-486-57Product
63323-484-57Product
63323-489-02Product
63323-489-27Product
63323-489-03Product
63323-489-21Product
63323-489-01Product
63323-489-17Product
63323-488-07Product
63323-488-37Product
63323-488-03Product
63323-488-31Product
63323-488-01Product
63323-488-17Product
63323-481-01Product
63323-481-57Product
63323-483-03Product
63323-483-27Product
63323-483-01Product
63323-483-57Product
63323-482-01Product
63323-482-17Product
63323-482-03Product
63323-482-27Product
63323-482-05Product
63323-482-57Product
63323-487-01Product
63323-487-17Product
63323-487-07Product
63323-487-37Product
63323-487-03Product
63323-487-31Product
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.
