Cipla recalls over 400 cartons of cancer drug in US

Metro India News | NEW DELHI 

Cipla’s US subsidiary is recalling more than 400 cartons of its generic anti-cancer drug Nilotinib in the United States due to a manufacturing issue, the US Food and Drug Administration (USFDA) has reported.

Warren, New Jersey-based Cipla USA, Inc is recalling Nilotinib Capsules in 150 mg and 200 mg strengths. The affected lots include 271 and 164 cartons, identified as failing tablet and capsule specifications. The company initiated the Class III voluntary recall on February 18 this year.

According to the USFDA, a Class III recall indicates that the use of the product is unlikely to cause adverse health consequences. Nilotinib works by blocking the action of abnormal proteins that signal cancer cells to multiply, helping to slow or stop the growth of cancer.

India is home to the largest number of USFDA-compliant pharmaceutical plants outside the United States. Indian drugmakers play a key role in supplying medicines to US residents. In 2022, four out of every ten prescriptions filled in the US were supplied by Indian pharmaceutical companies.

Cipla’s recall highlights ongoing challenges in drug manufacturing quality control, even as Indian firms continue to be major contributors to global pharmaceutical supplies. The company has communicated with distributors and healthcare providers in the US to ensure the affected lots are removed from circulation, emphasizing patient safety.