October 2014 FDA Recall Emtriva by Gilead Sciences, Inc.
D-0045-2015 - Defective Container; leaking around the cap

This Class II drug recall was voluntarily initiated by Gilead Sciences, Inc. on October 1, 2014 for the product Emtriva. The FDA reported the reason for recall as defective container; leaking around the cap. The product was distributed in United States, Puerto Rico, Fiji. and the recall is currently terminated.

Recall Number: D-0045-2015

Reason for Recall
Defective Container; leaking around the cap
Initiated
10-01-2014
Reported
11-05-2014
Quantity
6,290 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69411
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gilead Sciences, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States, Puerto Rico, Fiji.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-11-2015
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 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

Affected Packages Involved in this Recall

61958-0601-1 Emtriva
61958-0602-1 Emtriva