Prescription Rizatriptan Benzoate Tablets Recalled for Chemical Impurity
Glenmark Pharmaceuticals recalls Rizatriptan Benzoate 5mg tablets due to excess N-Nitroso Desmethyl Rizatriptan impurity. The nationwide recall affects 3,480 cartons with lots 19233788 and 19224445.
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 FDA Class II recall involves a chemical impurity (N-Nitroso Desmethyl Rizatriptan) exceeding acceptable limits due to manufacturing control deviations. With no reported illnesses or injuries, this represents a risk-of-harm situation where preventive action is warranted, consistent with High severity classification.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling 3,480 cartons of Rizatriptan Benzoate Tablets USP, 5mg across the United States due to a manufacturing quality deviation. Testing identified N-Nitroso Desmethyl Rizatriptan impurity levels that exceed FDA acceptable limits.
The affected products include Lot 19233788 (expiration 9/2025) and Lot 19224445 (expiration 9/2024). These tablets are distributed nationwide with NDC codes 68462-465-99 and associated package codes.
Consumers taking Rizatriptan Benzoate from the affected lots should consult their healthcare provider or pharmacist immediately. Do not discontinue use of the medication without medical guidance, as doing so may affect migraine treatment. Return unused medication to the pharmacy.
Healthcare providers should identify patients who received affected lots and consider alternative treatments or re-dispensing from unaffected inventory.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- nitrosamine-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 (3)
- Lot#: 19233788
- Exp. 9/2025 Lot#: 19224445
- Exp. 9/2024
UPCs (2)
- 0368462465998
- 0368462466995
Distribution
Distributed nationwide across the United States.
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- HighFDA Recalls Rizatriptan Benzoate Tablets for Manufacturing Impurity
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FDA (Drugs) · 2024-06-12
- HighPrescription migraine drug recalled for manufacturing impurity above FDA limit
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