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 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.
The product failed tablet/capsule specifications. Stability testing at 6 months showed out-of-spec results for Description and Appearance by Visual Inspection tests.
1. Stop using the product. 2. Contact Cipla USA, or your healthcare provider for guidance. 3. Await further instructions by Cipla via recall notification letter.
Manufacturer: Cipla Ltd., Verna, Goa, India. Manufactured for Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. FDA recall page available at the provided enforcement link.
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