United StatesNilotinib Capsules 150 mg and 200 mg, Rx only, in cartons (outer carton 112 capsules — 4 packs of 28; inner carton 28 capsules — 4 blisters of 7; foil blister) with NDCs 69097-031-74/56/17 (150 mg) and 69097-032-74/56/17 (200 mg), lots 5GJ0220, 5GJ0221, 5GJ0222, 5GJ0223, exp 04/30/2027, manufactured for Cipla USA and sold nationwide, are being recalled. The products were recalled after observed out-of-specification results at six-month long-term stability for the Description test and Appearance by Visual Inspection test.
What's being recalled
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
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, 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 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
Recalling firm: Cipla USA, Inc., Warren, NJ, United States.
How to identify it
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027 Lot #: 5GJ0223, Exp 04/30/2027
The hazard
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S.A. Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)