Cardinal Health Recalls Integra 325/40/3mg Due to Temperature Excursions
Cardinal Health is recalling 32 bottles of Integra 325/40/3mg due to intermittent temperature excursions during storage.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a storage deviation (temperature excursion) which is a potential quality issue rather than a confirmed high-risk pathogen or structural defect, fitting the Moderate criteria for low-risk contamination or precautionary measures.
Plain-English summary
Cardinal Health Inc. is recalling 32 bottles of INTEGRA 325/40/3mg 90-count (NDC: 52747-710-60). The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected lots were distributed between February 23, 2021, and March 10, 2021. Distribution was limited to Florida, Georgia, and South Carolina.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement.
The recalled product
- Product
- INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Oral Solid Dosage
- Affected units
- 32
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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