Drug Recall: Zonisamide Capsules Due to Manufacturing Deviations
Glenmark Pharmaceuticals is recalling 12,003 bottles of Zonisamide 50 mg capsules nationwide due to manufacturing deviations.
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 recall is FDA Class II and was voluntary with no reported illnesses or injuries. The hazard is a manufacturing process deviation without a specific confirmed product defect, making this a precautionary recall. Voluntary precautionary recalls are classified as Moderate severity.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles. The recall affects 12,003 bottles distributed nationwide in the United States.
The recall was initiated due to cGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. This was a voluntary recall initiated by the firm and classified by the FDA as Class II.
The recalled product is identified by Lot #29200064 with an expiration date of 5/31/2023. Patients currently taking this medication should contact their healthcare provider for guidance before discontinuing or replacing their medication. Healthcare providers and pharmacists should identify and quarantine any bottles matching the recalled lot number.
The recalled product
- Product
- ZONISAMIDE (ZONISAMIDE)
- Brand
- ZONISAMIDE
- 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 (2)
- Lot #: 29200064
- Exp 5/31/2023
UPCs (3)
- 0368462130018
- 0368462129012
- 0368462128015
Distribution
Distributed nationwide across the United States.
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