FDA recall D-0010-2025

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.

Distribution

Nationwide within the United States and PR

Key facts

Status

Terminated

Initiation date

2024-10-01

Report date

2024-10-23

Termination date

2026-02-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raleigh, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2025