Recalls / Class II

Class IID-0154-2017

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

Affected 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

Why it was recalled

Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container

Recalling firm

Firm

Par Pharmaceutical, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1 Ram Ridge Rd, Chestnut Ridge, New York 10977-6714

Distribution

Quantity

a) 182,856 bottles; b) 59,448 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2016-10-05

FDA classified

2016-11-25

Posted by FDA

2016-12-07

Terminated

2018-06-18

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0154-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.