Cardinal Health Recalls Darifenacin Tablets Due to Temperature Excursions
Cardinal Health is recalling 37 bottles of Darifenacin Extended-release Tablets 15 mg due to intermittent temperature excursions during storage.
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 classified as FDA Class II due to CGMP deviations (temperature excursions) without reported injuries or illnesses, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Cardinal Health Inc. is recalling 37 bottles of Darifenacin Extended-release Tablets 15 mg (NDC 13668-203-30). The product was manufactured by Torrent Pharmaceuticals, LTD in India for Torrent Pharma Inc. in Basking Ridge, NJ. The recall is due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed to Florida, Georgia, and South Carolina. The specific lot code is BDZ9G005.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DARIFENACIN (DARIFENACIN)
- Brand
- DARIFENACIN
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 37
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 (1)
- BDZ9G005
UPCs (2)
- 0313668202304
- 0313668203301
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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