Drug recall D-0010-2025

Class II Terminated reported Oct 23, 2024

Product

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.

Lots and codes

Lot #: P2202009, Exp. Date: 03/2025

Recall details

Recalling firm
ACCORD HEALTHCARE, INC., Raleigh, NC
Quantity
11,214 vials
Distribution
Nationwide within the United States and PR
Type
Voluntary: Firm initiated
Recall initiated
October 1, 2024
Terminated
February 23, 2026

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