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
Reported: November 15, 2023 Initiated: October 20, 2023 #D-0095-2024
Product Description
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
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 5,856 bottles
- Distribution
- USA nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 5,856 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 15, 2023. Severity: Moderate. Recall number: D-0095-2024.
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