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
This recall has been terminated (originally issued December 7, 2016).
- Company
- Par Pharmaceutical, Inc.
- Recall Initiated
- October 5, 2016
- Posted
- December 7, 2016
- Recall Number
- D-0154-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 182,856 bottles; b) 59,448 bottles
- Firm Location
- Chestnut Ridge, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Distribution
Nationwide
Lot / Code Info
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