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
Reported: October 6, 2021 Initiated: September 17, 2021 #D-0856-2021
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
Reason for Recall
Defective container: Cracked vials leading to lack of sterility assurance
Details
- Recalling Firm
- Fresenius Kabi USA LLC
- Units Affected
- 963000 vials
- Distribution
- U.S.A. Nationwide
- Location
- Melrose Park, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA LLC. Units affected: 963000 vials.
Why was this product recalled? ▼
Defective container: Cracked vials leading to lack of sterility assurance
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 6, 2021. Severity: Moderate. Recall number: D-0856-2021.
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