June 2012 FDA Recall Drug by Glaxosmithkline Inc
D-1412-2012 - Adulterated Presence of Foreign Tablets

This Class II drug recall was voluntarily initiated by Glaxosmithkline Inc on June 4, 2012 for the product Drug. The FDA reported the reason for recall as adulterated presence of foreign tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1412-2012

Reason for Recall
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Initiated
06-04-2012
Reported
07-18-2012
Quantity
14,465 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62392
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.
GlaxoSmithKline 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-04-2014
Product Description About Product Description
Full technical description of the product.
Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18

Batch or Lot Expiration Information

Lot# 0ZP5128 exp; 8/2013