Emtriva Capsule
FDA Recall NDC 61958-0601
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Emtriva (NDC 61958-0601). A significant event, classified as Class II, was initiated on Oct 01, 2014 by Gilead Sciences, Inc.. The reported reason for this action was: "Defective Container; leaking around the cap"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container; leaking around the cap
Oct 01, 2014
Nov 05, 2014
6,290 bottles
Recall Profile & Regulatory Data
Event ID
69411
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Gilead Sciences, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States, Puerto Rico, Fiji.
Termination Date
May 11, 2015
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.
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
61958-0601-1Product
61958-0602-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
