Class II · Moderate risk
Emtriva (emtricitabine)
Defective Container; leaking around the cap
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1
Affected NDC
61958-0701-01
Compare with the code on your package — it is the most precise check available.
Drug: Emtricitabine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Truvada emtricitabine and tenofovir disoproxil fumarate NDC 61958-0701 |
EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 | Tablet, Film Coated Oral |
Gilead Sciences, Inc | Rx |
- Recalling firm
- Gilead Sciences, Inc.
- NDC code
- 61958-0701-1
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0013-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Emtricitabine recalls
See all
Class III · Low risk
Atripla
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Other recalls by Gilead Sciences, Inc.
All 2014 recalls
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: Presence of glass particle.
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class II · Moderate risk
Emtriva (emtricitabine)
Defective Container; leaking around the cap
Class III · Low risk
Atripla
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
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