The Recall Desk
ModerateFDA (Drugs)·D-0486-2021·Announced 2021-06-02

Cardinal Health Recalls Triumeq Tablets Due to Temperature Excursions

Cardinal Health is recalling 2,264 bottles of Triumeq 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 due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 2,264 bottles of Triumeq (abacavir sulfate, dolutegravir sodium, and lamivudine) 600 mg/50 mg/300 mg tablets. 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 the code GS5G and NDC 49702-231-13. It was distributed in Florida, Georgia, and South Carolina. Triumeq is a prescription medication used for the treatment of HIV-1 infection.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance on alternative treatment options. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE)
Brand
TRIUMEQ
Manufacturer
Cardinal Health Inc.
Category
Drug — Antiretroviral
Hazard
Affected units
2,264

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)

  • GS5G

UPCs (1)

  • 0349702231139

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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