Chemotherapy Drug Recalled

Accord Healthcare Inc. is recalling 11 214 vials of cisplatin injection after samples failed to meet impurity/degradation specifications during testing, according to the October 23, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects cisplatin injection, 100 mg/100 mL (1 mg/mL), in 100-mL multiple-dose vials (NDC 16729-288-38) from lot P2202009 (Exp. 3/25). The product was manufactured for Accord Healthcare, Durham, North Carolina, by Intas Pharmaceuticals Limited, Ahmedabad, India, and was distributed in the United States and in Puerto Rico.

Accord Healthcare initiated the recall October 1, 2024. The FDA designated the recall Class II on October 11, 2024. Drugs affected by Class II recalls may cause temporary or medically reversible

adverse health consequences if used. While remote, a possibility of serious harm also exists.
The product is indicated for intravenous use in the treatment of patients with advanced testicular, ovarian, or bladder cancer.