Recalls / Class II
Class IID-0095-2024
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
- Brand name
- Deferasirox
- Generic name
- Deferasirox
- Active ingredient
- Deferasirox
- Route
- Oral
- NDCs
- 68462-494, 68462-495, 68462-496
- FDA application
- ANDA209433
- Affected lot / code info
- 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
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 5,856 bottles
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2023-10-20
- FDA classified
- 2023-11-08
- Posted by FDA
- 2023-11-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0095-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.