FDA Drug recall D-0856-2021
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 v…
- FDA Drug
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of 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 v… by Fresenius Kabi Usa, citing defective container: Cracked vials leading to lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0856-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-17 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
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
Defective container: Cracked vials leading to lack of sterility assurance
Identifiers
| ndc | 63323-452-00 |
|---|---|
| ndc | 63323-452-01 |
| ndc | 63323-454-00 |
| ndc | 63323-454-01 |
| ndc | 63323-455-00 |
| ndc | 63323-455-01 |
| ndc | 63323-458-00 |
| ndc | 63323-458-01 |
| ndc | 63323-451-00 |
| ndc | 63323-451-01 |
| code_info | Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0856-2021%22
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