Drug product
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30
D-0095-2024
Product summary
- Event
- Event 93219
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,856 bottles
- Official record key
drug-enforcement:D-0095-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 17220063, Exp 12/2023; 17220396, 17220397, Exp 01/2024; 17220965, Exp 04/2024; 17221187, 17221523, Exp 07/2024; 17221793, 17221794, 17221801, Exp 08/2024
Distribution pattern: USA nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications