Drug 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.
D-0045-2015
Product summary
- Event
- Event 69411
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,290 bottles
- Official record key
drug-enforcement:D-0045-2015
Official wording
Reason: Defective Container; leaking around the cap
Code information: 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
Distribution pattern: United States, Puerto Rico, Fiji.
Derived failure modes
-
Unknown
Defective Container; leaking around the cap