Nilotinib

Cipla USA Inc. has initiated a voluntary Class III recall (D-0382-2026) for 164 cartons of Nilotinib Capsules, 200 mg, distributed nationwide. This action stems from out-of-specification results for description and visual appearance observed during 6-month long-term stability testing for Lot 5GJ0223. Procurement and regulatory teams must assess supply chain continuity for this critical oncology drug and scrutinize quality oversight for contract manufacturers.

Cipla USA, Inc. has initiated a Class III nationwide recall for specific lots of Nilotinib Capsules, 150 mg, due to out-of-specification results for description and appearance under long-term stability conditions. This voluntary action, impacting a critical oncology drug, necessitates immediate review of supply chain resilience by procurement and regulatory teams to mitigate potential patient access disruptions.