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Recall Observatory FDA recall evidence

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

October 01, 2014

Class II

Product summary

Firm
Gilead Sciences, Inc.
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

    reason.no_named_rule · v1.0.0

    Defective Container; leaking around the cap