FDA Recalls Rizatriptan Benzoate Tablets for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate 10mg tablets nationwide due to N-nitroso impurity levels exceeding FDA acceptable limits, affecting 13,296 cartons.
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 involving a chemical impurity exceeding acceptable limits. Although no illnesses or injuries have been reported in the source text, the detection of N-nitroso desmethyl rizatriptan impurity at levels above FDA acceptable limits represents a risk-of-harm situation that meets the High severity threshold.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Rizatriptan Benzoate orally disintegrating tablets, USP 10mg. The recall encompasses 13,296 cartons distributed nationwide.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. N-nitroso desmethyl rizatriptan impurity was detected at levels exceeding FDA acceptable limits in the affected tablets. Three lot numbers are affected: 19223402 (expiration 7/2024), 19224858 (expiration 11/2024), and 19232492 (expiration 6/2025).
The affected tablets were distributed to consumers in the United States. Consumers with affected lot numbers should consult with their healthcare provider or pharmacist regarding their medication supply.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- chemical-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 (4)
- Lot#: 19223402
- Exp. 7/2024 Lot#: 19224858
- Exp. 11/2024 Lot#: 19232492
- Exp. 6/2025
UPCs (2)
- 0368462467060
- 0368462468067
Distribution
Distributed nationwide across the United States.
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