Cardinal Health Recalls Theophylline Tablets Due to Temperature Excursions
Cardinal Health is recalling 141 bottles of Theophylline Extended-Release Tablets 400 mg due to intermittent exposure to 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. The hazard involves CGMP deviations related to temperature excursions, which is a quality control issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 141 bottles of Theophylline (Anhydrous) Extended-Release Tablets 400 mg. The product is identified by NDC 68462-380-01 and code 19205025. It was manufactured by Glenmark Pharmaceuticals Limited in India for Glenmark Pharmaceuticals Inc. in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected product was distributed to Florida, Georgia, and South Carolina.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class II by the FDA.
The recalled product
- Product
- THEOPHYLLINE (THEOPHYLLINE)
- Brand
- THEOPHYLLINE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 141
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)
- 19205025
UPCs (2)
- 0368462380017
- 0368462356012
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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