October 2016 FDA Recall Drug by Par Pharmaceutical, Inc.
D-0154-2017 - Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container

This Class II drug recall was voluntarily initiated by Par Pharmaceutical, Inc. on October 5, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; damage to the internal portion of the dropper tip portion of the container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0154-2017

Reason for Recall
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Initiated
10-05-2016
Reported
12-07-2016
Quantity
a) 182,856 bottles; b) 59,448 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75471
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.
Par Pharmaceutical, 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.
06-18-2018
Product Description About Product Description
Full technical description of the product.
Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977

Batch or Lot Expiration Information

Lot# a) G40814 - Exp. Date 09/2016, GA50089 - Exp. Date 12/2016, GA50259 - Exp. Date 01/2017, GA50657 - Exp. Date 03/2017, GA51073 - Exp. Date 06/2017, GA51651 - Exp. Date 09/2017, GA51652 - Exp. Date 09/2017, GA51722 - Exp. Date 09/2017, GA51723 - Exp. Date 09/2017, GA51760 - Exp. Date 10/2017, and GA51761 - Exp. Date 10/2017 b) GA45033 - Exp. Date 10/2016, GA50258 - Exp. Date 01/2017, GA50944 - Exp. Date 05/2017, GA50174 - Exp. Date 06/2017, GA51340 - Exp. Date 07/2017, GA51479 - Exp. Date 08/2017, and GA51762 - Exp. Date 10/2017