Cardinal Health Recalls Vitamin D3 Supplements Due to Temperature Excursions
Cardinal Health Inc. is recalling 205 bottles of Vitamin D3 Cholecalciferol 50,000 IU dietary supplements 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 205 bottles of Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement, 12 capsules per bottle (NDC 75834-020-12). The product is marketed by Nivagen Pharmaceuticals, Inc. of Sacramento, CA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected lots were distributed between February 23, 2021, and March 10, 2021.
The product was distributed in Florida, Georgia, and South Carolina. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 205
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)
- All Lots distributed 02/23/2021 through 03/10/2021.
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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