FDA Recalls Deferasirox Tablets for Failed Dissolution Specifications
Glenmark Pharmaceuticals is recalling Deferasirox 500mg tablets nationwide due to failed dissolution specifications affecting approximately 5,856 bottles across multiple lots.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA drug recall for a pharmaceutical product with failed dissolution specifications. A dissolution failure in a medication represents a risk-of-harm to patients who depend on this drug for iron chelation therapy, meeting the criterion for High severity without reported illnesses or injuries.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Deferasirox Tablets for Oral Suspension (500mg) nationwide in the United States due to failed dissolution specifications. Approximately 5,856 bottles across multiple lot numbers are affected.
The recalled lot numbers are: #17220063 (Exp 12/2023), #17220396 and #17220397 (Exp 01/2024), #17220965 (Exp 04/2024), #17221187 and #17221523 (Exp 07/2024), and #17221793, #17221794, and #17221801 (Exp 08/2024). The product number is NDC 68462-496-30, manufactured in India for Glenmark Pharmaceuticals Inc.
Deferasirox is an iron chelating agent used to treat chronic iron overload. The FDA classification for this recall is Class II.
The recalled product
- Product
- DEFERASIROX (DEFERASIROX)
- Brand
- DEFERASIROX
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Iron Chelator
- Hazard
- Affected units
- 5,856
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distributed nationwide across the United States.
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