The Recall Desk
ModerateFDA (Drugs)·D-0460-2021·Announced 2021-06-02

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.

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, 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
Hazard
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

Distributed in 3 states:

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.

See all 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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