Cipla USA, Inc.: Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipl
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- 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 III
- Status
- Ongoing
- Distribution / sold at
- U.S.A. Nationwide
- Recall initiated
- 2026-02-18
- Code info
- Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
- Product quantity
- 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warren
- State
- NJ
- Country
- United States
- Event id
- 98452
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