Recalls / Class II
Class IID-0045-2015
Product
Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404.
- Brand name
- Emtriva
- Generic name
- Emtricitabine
- Active ingredient
- Emtricitabine
- Route
- Oral
- NDCs
- 61958-0601, 61958-0602
- FDA application
- NDA021500
- Affected lot / code info
- 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
Why it was recalled
Defective Container; leaking around the cap
Recalling firm
- Firm
- Gilead Sciences, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 333 Lakeside Dr, N/A, Foster City, California 94404-1147
Distribution
- Quantity
- 6,290 bottles
- Distribution pattern
- United States, Puerto Rico, Fiji.
Timeline
- Recall initiated
- 2014-10-01
- FDA classified
- 2014-10-24
- Posted by FDA
- 2014-11-05
- Terminated
- 2015-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0045-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.