Cipla USA recalls 271 cartons of Nilotinib 150 mg capsules nationwide after stability tests show out-of-spec results. The issue affects description and appearance by visual inspection. Stop using and contact Cipla USA or a clinician for guidance.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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Nilotinib is a prescription tyrosine kinase inhibitor used to treat certain leukemias. This recall involves 150 mg capsules distributed in the United States.
Stability-related failures can affect potency and appearance, potentially impacting drug efficacy and safety.
This recall is not described as part of a broader industry pattern in the notice.
Patients relying on Nilotinib for cancer treatment may be affected. There is no reported injury in the notice, but the medication could be subpotent or misrepresented until resolved.
Cipla USA contact details at 10 Independence Boulevard, Suite 300, Warren, NJ 07059. FDA recall page: enforce_rpt-Product-Tabs.cfm?recall_number=D-0381-2026
Recall is active; no refund details provided. Follow Cipla guidance and clinician instructions. Replacement or compensation not specified.
Keep recall notice, packaging, and any medical records related to the product for future reference
Nilotinib capsules, 150 mg, manufactured by Cipla Ltd. in Verna, Goa, India, for Cipla USA, Warren, NJ. Recall covers 271 cartons nationwide. Outer carton: 112 capsules (4 packs of 28). Inner carton: 28 capsules (4 blisters of 7). NDCs: 69097-031-74 (outer), 69097-031-56 (inner), 69097-031-17 (foil). Lot numbers: 5GJ0220, 5GJ0221, 5GJ0222. Expiration: 04/30/2027. Class III recall.
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