Home / Recalls / Fresenius Kabi USA, LLC / D-1386-2019

D-1386-2019 Class III Terminated

Recalled by Fresenius Kabi USA, LLC — Grand Island, NY

Recall Details

Product Type
Drugs
Report Date
June 19, 2019
Initiation Date
May 22, 2019
Termination Date
January 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,981 units

Product Description

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

Reason for Recall

Failed Impurities/Degradation Specifications.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 6018699, Exp. 12/2021

Other recalls by Fresenius Kabi USA, LLC

  • D-0429-2026 Class II — 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 B (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-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)
  • 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-0425-2026 Class II — 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, (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-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-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-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)