PlainRecalls
FDA Drug Moderate Class II Completed

Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01

Reported: March 15, 2023 Initiated: February 28, 2023 #D-0435-2023

Product Description

Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01

Reason for Recall

Labeling: Not elsewhere classified

Details

Units Affected
28,875 vials
Distribution
USA Nationwide
Location
Schaumburg, IL

Frequently Asked Questions

What product was recalled?
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01. Recalled by Sagent Pharmaceuticals Inc. Units affected: 28,875 vials.
Why was this product recalled?
Labeling: Not elsewhere classified
Which agency issued this recall?
This recall was issued by the FDA Drug on March 15, 2023. Severity: Moderate. Recall number: D-0435-2023.