Nilotinib capsules manufactured for Cipla USA are recalled nationwide after stability testing showed out-of-spec results. The failure involves description and appearance by visual inspection at six months of long-term stability. Patients and healthcare providers should stop using the product immediately and contact Cipla USA 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 medicine used to treat certain leukemias. This recall focuses on a quality-control issue affecting stability and appearance.
A six-month stability failure may affect the description and visual appearance of the capsules, potentially impacting potency or quality.
This recall is not described as part of a broader industry pattern.
No injuries or deaths reported in the recall. The quality issue could affect treatment effectiveness if affected packaging is used.
NDCs, lot number, and expiration date are printed on the packaging. FDA recall page linked in the notice provides official details.
Recall is active. Replacement or guidance will be provided by Cipla USA; no refund information is provided for prescription medication.
Keep the recall notice, packaging, lot and expiration dates, and all correspondence with Cipla USA for records.
Rx-only Nilotinib capsules, 200 mg per capsule. Outer carton contains 112 capsules (4 packs of 28). Inner carton contains 28 capsules (4 blisters of 7). NDCs: 69097-032-74 (outer), 69097-032-56 (inner), 69097-032-17 (foil blister). Lot number: 5GJ0223. Expiration: 04/30/2027. Quantity recalled: 164 cartons. Sold nationwide in the USA. Distributed by Cipla USA, Inc., Warren, NJ. Model numbers are not applicable; packaging references. Status: Active recall with Class III designation.
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