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.
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 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
- 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
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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