RecallRadar

FDA Drug recall D-0435-2023

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:…

On 2023-03-15 the FDA classified a Class II recall of 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:… by Sagent Pharmaceuticals, citing labeling: Not elsewhere classified.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0435-2023
ClassificationClass II
Statusterminated
Initiated2023-02-28
Published2023-03-15
Last updated2026-09-13 11:52 UTC
CompanySagent Pharmaceuticals
DistributionUS

Product

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

Labeling: Not elsewhere classified

Identifiers

ndc25021-404-01
code_infoLot#: WP201, Exp 2/2024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0435-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.