FDA-Drug2026-03-11Class III

Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17

Cipla USA, Inc.

Hazard

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Sold states

U.S.A. Nationwide

Affected count

271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules

Manufactured in

10 Independence Blvd, N/A, Warren, NJ, United States

Products

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0381-2026

Original summary

Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17 Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027 Distribution: U.S.A. Nationwide Affected quantity: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules

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