FDA Recall D-0095-2024
Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ
Class II Ongoing 937 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Failed Dissolution Specifications
Recall record
- Recall number
D-0095-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA nationwide
- Recall initiated
- 2023-10-20
- Classified by FDA Center
- 2023-11-08
- FDA published
- 2023-11-15
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Firm location
- Mahwah, NJ
Drug identification
- Brand name(s)
- DEFERASIROX
- Generic name(s)
- DEFERASIROX
- Manufacturer(s)
- Glenmark Pharmaceuticals Inc., USA
- NDC(s)
68462-494, 68462-495, 68462-496- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.