Frovatriptan Succinate tablets recalled due to manufacturing deviations
Glenmark Pharmaceuticals Inc., USA is recalling Frovatriptan Succinate 2.5mg tablets nationwide due to current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this as a Class II recall.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II, and the source indicates CGMP deviations without reported illness or injury. Under the rubric, FDA Class II without hospitalization or reported adverse health consequences typically scores as Moderate (2).
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Frovatriptan Succinate Tablets 2.5mg (NDC# 68462-694-97) in 9-count bottles distributed nationwide in the United States. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
The affected lots are Lot # 17231352 (expiration date Jun-25) and Lot # 17231649 (expiration date Jul-25). This is a voluntary recall initiated by the manufacturer and classified by the FDA as Class II.
Patients currently taking this product should contact their healthcare provider or pharmacist for guidance. Do not stop taking the medication without consulting a healthcare professional, as abrupt discontinuation may cause harm. Healthcare providers and patients with questions can contact the FDA or the manufacturer, Glenmark Pharmaceuticals Inc., USA, located in Mahwah, NJ.
The recalled product
- Product
- FROVATRIPTAN SUCCINATE (FROVATRIPTAN SUCCINATE)
- Brand
- FROVATRIPTAN SUCCINATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- cgmp-deviation
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 # 17231352
- exp. date Jun-25 17231649
- exp. date Jul-25
Distribution
Distributed nationwide across the United States.
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