Cardinal Health Recalls Norvir Ritonavir Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 362 bottles of Norvir (ritonavir) 100 mg tablets distributed in Florida, Georgia, and South Carolina 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, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a storage condition deviation (temperature excursion) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 362 bottles of Norvir (ritonavir) 100 mg tablets, 30-count bottles. The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by NDC 0074-3333-30 and code 1131141. The recall is limited to product distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers with this product should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- NORVIR (RITONAVIR)
- Brand
- NORVIR
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Antiretroviral
- Affected units
- 362
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)
- 1131141
UPCs (1)
- 0300742340304
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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