Fosaprepitant for Injection — Class III drug recall D-1391-2020
Terminated recall by Fresenius Kabi USA, LLC, reported 2020-07-22, distributed nationwide. Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quant
| Recall number | D-1391-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2020-07-13 |
| Classified | 2020-07-16 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2022-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 63,067 vials |
| Reason classes | labeling, potency |
| NDC | 63323-0972, 63323-0972-10 |
| Lot numbers | 6122760, 6122761, 6122762, 6123883 |
| Expiration dates | 2021-08, 2021-09, 2022-03 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1391-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.