Class II

Drug Recall: 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 L

ACCORD HEALTHCARE, INC. · October 1, 2024

Reason for Recall

Failed Impurities/Degradation Specifications.

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

Distribution

Nationwide within the United States and PR

States Affected

NATIONWIDE

Quantity Affected

11,214 vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0010-2025

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.