FDA Drug recall D-1391-2020
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047
- FDA Drug
- Class III
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class III recall of Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 by Fresenius Kabi Usa, citing labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1391-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-07-13 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
Reason
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Identifiers
| ndc | 63323-972-10 |
|---|---|
| code_info | Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022 |
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-1391-2020%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.