Cardinal Health Recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets for Temperature Excursions
Cardinal Health Inc. is recalling 235 bottles of Bisoprolol Fumarate and Hydrochlorothiazide tablets 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 and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 235 bottles of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, 100-count bottles. The product is distributed by Teva Pharmaceuticals USA, Inc., and is identified by NDC 0093-3241-01 and code 1417295A.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Consumers with this product should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 235
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)
- 1417295A
UPCs (2)
- 0300933241014
- 0300933243568
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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