Cardinal Health Recalls Calcium Acetate Capsules Due to Temperature Excursions
Cardinal Health is recalling 35 bottles of Calcium Acetate Capsules 667 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, and the hazard involves a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 35 bottles of Calcium Acetate Capsules 667 mg (NDC 23155-531-02). The product is a prescription-only medication manufactured for Heritage Pharmaceuticals Inc. The recall is limited to specific units identified by lot number L200801.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This issue may affect the stability or quality of the medication.
The affected product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers who have this specific lot of Calcium Acetate Capsules should stop using it and contact their pharmacist or physician for guidance on replacement or disposal.
The recalled product
- Product
- CALCIUM ACETATE (CALCIUM ACETATE)
- Brand
- CALCIUM ACETATE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 35
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)
- L200801
UPCs (2)
- 0323155531107
- 0323155531022
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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