Viiv Healthcare Recalls Tivicay Tablets Due to Cross-Contamination with Promacta
Viiv Healthcare is recalling 1,056 bottles of Tivicay (dolutegravir) 50 mg tablets because they were found to contain Promacta (eltrombopag). The recall covers products distributed nationwide, including Puerto Rico.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard involves cross-contamination with another drug, which is a significant quality issue but does not meet the criteria for higher severity scores in the absence of reported injuries or specific high-risk pathogen involvement.
Plain-English summary
Viiv Healthcare Company is recalling 1,056 bottles of Tivicay (dolutegravir) 50 mg tablets. The recall is being conducted because the product was found to be cross-contaminated with Promacta (eltrombopag). The affected product is identified by Lot # 3ZP2210 Sub-lot A and has an expiration date of 10/15. The NDC for the recalled product is 49702-228-13.
The recalled Tivicay tablets were distributed nationwide, including Puerto Rico. Tivicay is a prescription-only medication manufactured for ViiV Health and by GlaxoSmithKline. The product is made in Japan.
Consumers and healthcare providers should stop using the affected Tivicay tablets and contact their healthcare provider for guidance on alternative treatment options. Patients should not discontinue their HIV treatment without consulting their doctor.
The recalled product
- Product
- TIVICAY (DOLUTEGRAVIR SODIUM)
- Brand
- TIVICAY
- Manufacturer
- Viiv Healthcare Company
- Category
- Drug — Antiretroviral
- Affected units
- 1,056
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 (2)
- Lot #: 3ZP2210 Sub-lot A
- Expiry: 10/15
UPCs (3)
- 0349702227132
- 0349702226135
- 0349702228139
Distribution
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