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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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.
The recall stems from observed out-of-spec tablet/capsule specifications. Six-month long-term stability testing failed for Description and Appearance by Visual Inspection. The issue may affect potency or appearance, prompting recall.
1. Stop using the product. 2. Contact Cipla USA, Inc. at the address listed below for guidance. 3. Consult your healthcare provider if you have questions about implications for treatment. 4. For information, refer to the FDA recall enforcement page linked in the notice.
Recall notification is posted on the FDA enforcement site: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0382-2026. Cipla USA, Inc. address: 10 Independence Boulevard, Suite 300, Warren, NJ 07059. No public phone or hours are listed in the provided materials.
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