Why it was recalled
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Product description
Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland
Lot numbers, UPCs & expiration codes
Lot #'s: 002390, 002400, Exp 02/17.
Where it was sold
Nationwide including Puerto Rico.
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-1090-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 19, 2014
- FDA report date
- Mar 5, 2014
- Quantity
- 39,223 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gilead Sciences, Inc.
Original FDA data
Every field from FDA enforcement report D-1090-2014, exactly as published.
Show all FDA fields
- City
- Foster City
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 67557
- Address
- 333 Lakeside Dr
- Code information
- Lot #'s: 002390, 002400, Exp 02/17.
- Postal code
- 94404-1147
- Report date
- Mar 5, 2014
- Product type
- Drugs
- Recall number
- D-1090-2014
- Classification
- Class III
- Recalling firm
- Gilead Sciences, Inc.
- Product quantity
- 39,223 bottles
- Termination date
- May 11, 2015
- Reason for recall
- Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland
- Distribution pattern
- Nationwide including Puerto Rico.
- Recall initiation date
- Feb 19, 2014
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2014