The Recall Desk
ModerateFDA (Drugs)·D-0404-2021·Announced 2021-06-02

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.

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 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
Hazard
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

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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