New Delhi, March 8 A US-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the US Food and Drug Administration (USFDA).
Cipla USA, Inc, based in Warren (New Jersey), is recalling Nilotinib Capsules in two strengths (150 mg and 200 mg), the US health regulator said in its latest Enforcement Report.
The company is recalling the affected batch (271 and 164 cartons) due to "failure to meet specifications for tablets/capsules", 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 the US.
Indian pharmaceutical companies supply a substantial proportion of drugs to US residents, with four out of 10 of all prescriptions filled in the US in 2022 being supplied by Indian companies.
