Cardinal Health Recalls Pravachol 40mg Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling Pravachol 40mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a storage deviation (temperature excursion) rather than a confirmed contamination or defect causing injury, fitting the Moderate criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling Pravachol 40mg tablets (NDC 3519410) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage.
The affected product consists of 3 bottles of Pravachol 40mg tablets. The distribution pattern for this recall includes Florida, Georgia, and South Carolina. The specific lot code associated with this recall is ABA4203A1.
Consumers who have this product should check their inventory for the specific NDC and lot code. If the product matches the recalled description, they should contact their pharmacist or healthcare provider for guidance on disposal or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 3
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)
- ABA4203A1
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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