Prescription migraine drug recalled for manufacturing impurity above FDA limit
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons 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 a manufacturing defect involving an impurity exceeding acceptable limits in a prescription medication. No illnesses or injuries have been reported in the source text, so the hazard remains theoretical. Per the rubric, theoretical hazards with no reported injury score at most 3.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Rizatriptan Benzoate Orally Disintegrating Tablets, 5mg (NDC 68462-467 and 68462-468), manufactured in India. The recall is due to manufacturing deviations where testing detected N-Nitroso Desmethyl Rizatriptan impurity at levels exceeding FDA acceptable limits.
The affected product was distributed nationwide in the United States. Two lot numbers are involved: Lot #19224857 (expiration 11/2024) and Lot #19232493 (expiration 6/2025). A total of 2,400 cartons were distributed.
Patients taking Rizatriptan Benzoate from the affected lots should contact their healthcare provider or pharmacy. Do not discontinue use of the medication without consulting a healthcare professional, as this could affect migraine treatment. Return the medication to a pharmacy or dispose of it according to local guidelines.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- manufacturing-defect
- impurity
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 (3)
- Lot#: 19224857
- Exp. 11/2024 Lot#: 19232493
- Exp. 6/2025
UPCs (2)
- 0368462467060
- 0368462468067
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · RIZATRIPTAN BENZOATE
- HighFDA Recalls Rizatriptan Benzoate Tablets for Manufacturing Impurity
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- HighPrescription Rizatriptan Benzoate Tablets Recalled for Chemical Impurity
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- ModerateRizatriptan Benzoate Tablets Recalled for Out-of-Specification Impurities
FDA (Drugs) · 2021-11-03
- LowRizatriptan Benzoate Orally Disintegrating Tablets Recalled for Out-of-Specification Impurities
FDA (Drugs) · 2021-11-03
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