D-0382-2026 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2026
- Initiation Date
- February 18, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164 cartons
Product Description
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
Reason for Recall
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 5GJ0223, Exp 04/30/2027