Home / Recalls / Gilead Sciences, Inc. / D-0045-2015

D-0045-2015 Class II Terminated

Recalled by Gilead Sciences, Inc. — Foster City, CA

Recall Details

Product Type
Drugs
Report Date
November 5, 2014
Initiation Date
October 1, 2014
Termination Date
May 11, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,290 bottles

Product Description

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.

Reason for Recall

Defective Container; leaking around the cap

Distribution Pattern

United States, Puerto Rico, Fiji.

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

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  • D-0013-2015 Class III — Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, (September 30, 2014)
  • D-1090-2014 Class III — Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 3 (February 19, 2014)
  • D-821-2013 Class II — AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusio (June 20, 2013)
  • D-324-2013 Class I — Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, (January 31, 2013)