Morphine Sulfate Injection, Solution
FDA Recall NDC 63323-458
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 Morphine Sulfate (NDC 63323-458). A significant event, classified as Class II, was initiated on Sep 17, 2021 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Defective container: Cracked vials leading to lack of sterility assurance"
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
Defective container: Cracked vials leading to lack of sterility assurance
Sep 17, 2021
Oct 06, 2021
963000 vials
Recall Profile & Regulatory Data
Event ID
88698
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Jun 20, 2023
Product Description
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper
Batch or Lot Expiration Information
Lot# 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
Affected Packages Involved in this Recall
63323-452-00Product
63323-452-01Product
63323-454-00Product
63323-454-01Product
63323-455-00Product
63323-455-01Product
63323-458-00Product
63323-458-01Product
63323-451-00Product
63323-451-01Product
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.
