D-0154-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 7, 2016
- Initiation Date
- October 5, 2016
- Termination Date
- June 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 182,856 bottles; b) 59,448 bottles
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Distribution Pattern
Nationwide
Code Information
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