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FDAFDA · Food and drugs·Recall number D-0010-2025

Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38

Published October 23, 2024 · Recall initiated: October 1, 2024

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Impurities/Degradation Specifications.

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
CISPLATIN
Manufacturer
ACCORD HEALTHCARE, INC.
Distributor
Nationwide within the United States and PR
UPC
0316729288385
Lot
Lot #: P2202009, Exp. Date: 03/2025
Risk classification
Class II
Area (FDA)
drug
Country
United States

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