Class II
Terminated
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
This recall has been terminated (originally issued October 6, 2021).
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- September 17, 2021
- Posted
- October 6, 2021
- Recall Number
- D-0856-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 963000 vials
- Firm Location
- Melrose Park, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective container: Cracked vials leading to lack of sterility assurance
Distribution
U.S.A. Nationwide
Lot / Code Info
Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
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