CLASS III Drug recall · Reported 22 Jul 2020 · FDA Enforcement Report
Fosaprepitant for Injection, 150 mg / vial in a Single-Dose vial recalled
Fresenius Kabi USA is recalling Fosaprepitant for Injection, 150 mg / vial in a Single-Dose vial, distributed nationwide in the US. The recall was initiated on 13 Jul 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1391-2020
- FDA event ID
- 86018
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Brand
- Fosaprepitant
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Jul 2020
- FDA classified
- 16 Jul 2020
- Reported
- 22 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Jul 2020 | Recall initiated by company | |
| 16 Jul 2020 | Classified by FDA | +3 days |
| 22 Jul 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Fosaprepitant recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fosaprepitant for Injection 150 mg per vial recalledFosaprepitant | BE Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Fosaprepitant 150 mg/ NS Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |