FDA Drug recall D-1446-2020
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc
- FDA Drug
- Class II
- terminated
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class II recall of Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc by Pfizer, citing lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1446-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-20 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | PR |
Product
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Reason
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Identifiers
| ndc | 0409-9093-41 |
|---|---|
| ndc | 0409-9093-36 |
| ndc | 0409-9093-31 |
| ndc | 0409-9093-38 |
| ndc | 0409-9094-12 |
| ndc | 0409-9094-22 |
| ndc | 0409-9094-18 |
| ndc | 0409-9094-25 |
| ndc | 0409-9094-17 |
| ndc | 0409-9094-28 |
| ndc | 0409-9094-16 |
| ndc | 0409-9094-31 |
| ndc | 0409-9094-41 |
| ndc | 0409-9094-61 |
| ndc | 0409-9094-44 |
| ndc | 0409-9094-55 |
| code_info | Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021 |
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-1446-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.