Drug recall: Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx…
Class III FDA enforcement event 67557. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Gilead Sciences, Inc. started this drug recall on 19 Feb 2014. The firm address in the FDA record is in Foster City, CA. FDA put the recall in Class III. FDA event 67557 has 1 product record. The first FDA enforcement report date is 5 Mar 2014. The record gives the status Terminated, with the termination date 11 May 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide including Puerto Rico.
Recalling firm
Gilead Sciences, Inc., Foster City, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1090-2014 | 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… | 39,223 bottles | Class III | Terminated | 5 Mar 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Drug events that started in 2014
- 313
- Share of these events in Class III
- 27%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Sep 2024 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Fos | Drug | Class I | 1 |
| 3 Dec 2021 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Fos | Drug | Class I | 1 |
| 1 Oct 2014 | Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster | Drug | Class II | 1 |
| 30 Sep 2014 | Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured | Drug | Class III | 1 |
| 20 Jun 2013 | AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Market | Drug | Class II | 1 |
| 31 Jan 2013 | Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc. | Drug | Class I | 1 |
Official channels
- FDA enforcement report D-1090-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 67557. https://recallregister.com/fda/iii/67557/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide including Puerto Rico.
- What quantity of product is in FDA event 67557?
- The FDA record gives this quantity:
39,223 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2014 have the same class?
- 27% of the 313 drug events that started in 2014 are in Class III.