The Recall Desk
ModerateFDA (Drugs)·D-0045-2015·Announced 2014-11-05

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.

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, 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
Hazard
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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