Why it was recalled
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Product description
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
Lot numbers, UPCs & expiration codes
TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0013-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 30, 2014
- FDA report date
- Oct 15, 2014
- Quantity
- 10,317 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gilead Sciences, Inc.
Original FDA data
Every field from FDA enforcement report D-0013-2015, exactly as published.
Show all FDA fields
- City
- Foster City
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 69414
- Address
- 333 Lakeside Dr
- Code information
- TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017
- Postal code
- 94404-1147
- Report date
- Oct 15, 2014
- Product type
- Drugs
- Recall number
- D-0013-2015
- Classification
- Class III
- Recalling firm
- Gilead Sciences, Inc.
- Product quantity
- 10,317 bottles
- Termination date
- May 11, 2015
- Reason for recall
- Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 30, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2014