Cipla Usa, Inc.: Nilotinib Capsules, 150 Mg Per Capsule
- Recalling firm
- Cipla USA, Inc.
- Product
- 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
- Reason
- Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-02-18
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S.A. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/85f055a7-6291-4375-b050-b410aab03d50