Rizatriptan Benzoate Tablets Recalled for Excessive N-Nitroso Impurity
Glenmark Pharmaceuticals recalls certain Rizatriptan Benzoate tablets due to N-Nitroso Desmethyl Rizatriptan impurity levels exceeding FDA acceptable limits. The affected lots were distributed nationwide.
What this means for you
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 an FDA Class II recall for impurity contamination above FDA acceptable limits. Per the severity rubric, FDA Class II recalls for manufacturing deviations represent a risk-of-harm product, warranting a High severity classification.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling certain lots of Rizatriptan Benzoate Tablets USP, 10 mg due to current good manufacturing practice (CGMP) deviations. Testing identified N-Nitroso Desmethyl Rizatriptan impurity levels that exceed FDA acceptable limits.
The affected lots—19224217 (expiration 9/2024), 19233789 (expiration 9/2025), and 19224444 (expiration 9/2024)—total approximately 11,976 cartons distributed nationwide throughout the United States.
Patients currently using affected lots should contact their healthcare provider or pharmacist for guidance. Do not dispose of medication in household waste; consult a pharmacy or poison control center for proper disposal instructions.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- impurity
- manufacturing-defect
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 (4)
- Lot#: 19224217
- Exp. 9/2024 Lot#: 19233789
- Exp. 9/2025 Lot#: 19224444
- Exp. 9/2024
UPCs (2)
- 0368462465998
- 0368462466995
Distribution
Distributed nationwide across the United States.
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