FDA-Drug2024-10-23Class II
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
ACCORD HEALTHCARE, INC.
Hazard
Failed Impurities/Degradation Specifications.
Sold states
Nationwide within the United States and PR
Affected count
11,214 vials
Manufactured in
8041 Arco Corporate Dr Ste 200, Raleigh, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2025Don't want to check this manually?
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