Gilead Recalls Emtriva Oral Solution Due to Defective Leaking Containers
Gilead Sciences is recalling 6,290 bottles of Emtriva Oral Solution because the containers are defective and leaking around the cap.
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, and the hazard is a defective container causing leakage, which is a packaging issue without reported injuries or illnesses.
Plain-English summary
Gilead Sciences, Inc. is recalling 6,290 bottles of Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles. The recall is being conducted because the product has a defective container that is leaking around the cap.
The affected product is a prescription-only medication manufactured for Gilead Sciences, Inc. in Foster City, CA. The specific lot numbers involved are HDNTD1 and HDNTD (exp 30-Jun-15), KCMGD and KCMGD1 (exp 31-Oct-15), KYGHA, KYGKA, and KYGKK (exp 30-Apr-16), and MZVBA and MZTZA (exp 31-Oct-16).
The product was distributed in the United States, Puerto Rico, and Fiji. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it is leaking.
The recalled product
- Product
- EMTRIVA (EMTRICITABINE)
- Brand
- EMTRIVA
- Manufacturer
- Gilead Sciences, Inc.
- Category
- Drug — Antiretroviral
- Affected units
- 6,290
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 (5)
- FG Lot Number: HDNTD1 and HDNTD exp 30-Jun-15
- KCMGD and KCMGD1 exp 31-Oct-15
- KYGHA
- KYGKA and KYGKK exp 30-Apr-16
- MZVBA and MZTZA exp 31-Oct-16
Distribution
Distributed in 1 state:
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