Home / Recalls / Fresenius Kabi USA, LLC / D-1391-2020

D-1391-2020 Class III Terminated

Recalled by Fresenius Kabi USA, LLC — Lake Zurich, IL

Recall Details

Product Type
Drugs
Report Date
July 22, 2020
Initiation Date
July 13, 2020
Termination Date
August 19, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
63,067 vials

Product Description

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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022

Other recalls by Fresenius Kabi USA, LLC

  • D-0428-2026 Class II — 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL (March 11, 2026)
  • D-0436-2026 Class II — 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL free (March 11, 2026)
  • D-0430-2026 Class II — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a (March 11, 2026)
  • D-0432-2026 Class II — 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a (March 11, 2026)
  • D-0426-2026 Class II — 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 (March 11, 2026)
  • D-0424-2026 Class II — 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 25 (March 11, 2026)
  • D-0434-2026 Class II — 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in (March 11, 2026)
  • D-0435-2026 Class II — 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL free (March 11, 2026)
  • D-0433-2026 Class II — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in (March 11, 2026)
  • D-0427-2026 Class II — 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL (March 11, 2026)