Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Onl...
FDA Recall #D-0010-2025 — Class II — October 1, 2024
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications.
Recalling Firm
ACCORD HEALTHCARE, INC. — Raleigh, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11,214 vials
Distribution
Nationwide within the United States and PR
Code Information
Lot #: P2202009, Exp. Date: 03/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated