Intas Recall Cisplatin Injection For Impurities

Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities. The drug product is manufactured by Intas Pharmaceuticals at their Pharmez facility in Ahmedabad, India. The recall was initiated after batch P2202009 failed for unspecified impurities, with impurity levels observed at 0.26-0.28% during stability studies exceeding the specification limit of 0.2%, at the 24-month timepoint.  Cisplatin injection is indicated for treatment of advanced cancer. The recall is handled by Inmar Inc and recall is being made with the knowledge of USFDA.

Intas Pharmez facility at Ahmedabad (FEI 3004011473) was issued a Warning letter by USFDA and the facility was placed under Import alert in June, 2023, following critical observations during an USFDA inspection. The deficiencies observed during the inspection included critical data integrity issues, poor chromatographic integration practices, lapses in process validation and analytical method validation.  However critical cancer medications including Cisplatin Injection were given exemption from import restrictions due to drug shortage concerns in US.

Related readings:

• USFDA Enforecement Report Intas, Cisplatin (Oct 2024)
• Recall Alert for Cisplatin (Intas), Board of Pharmacy, California
• USFDA Warning letter to Intas, Pharmez facility (July 2023)
• Qvents post on Intas USFDA 483 citing Data Integrity issues