Cipla recalls over 400 cartons of cancer drug in U.S.: USFDA

A U.S.-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the U.S. Food and Drug Administration (USFDA).

Warren (New Jersey)-based Cipla USA, Inc is recalling Nilotinib Capsules in two strengths (150 mg and 200 mg), the U.S. health regulator said in its latest Enforcement Report.

The company is recalling the affected lot (271 and 164 cartons) due to “failed tablet/capsule specifications”, it stated.

Cipla USA, Inc initiated the Class III voluntary recall on February 18 this year.

According to the USFDA, a Class III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.

Nilotinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

India has the highest number of USFDA-compliant pharmaceutical plants outside of the U.S.

Indian pharmaceutical companies supply a substantial proportion of drugs to US residents, with four out of 10 of all prescriptions filled in the U.S. in 2022 being supplied by Indian companies.