Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC
Summary
The FDA issued a Class II for Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fr by Fresenius Kabi USA LLC. Reason: Defective container: Cracked vials leading to lack of sterility assurance.
Details
Source
Drug Recall
External ID
D-0856-2021
Action Date
2021-10-06
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
Quantity Affected: 963000 vials
Reason for Recall
Defective container: Cracked vials leading to lack of sterility assurance
Distribution
U.S.A. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-17
Company
Melrose Park, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fresenius Kabi USA LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA LLC have FDA actions?
Fresenius Kabi USA LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0856-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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