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Recall Observatory FDA recall evidence

Drug 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

D-0154-2017

October 05, 2016

Class II

Product summary

Firm
Par Pharmaceutical, Inc.
Event
Event 75471
Status
Terminated
Classification
Class II
Quantity
a) 182,856 bottles; b) 59,448 bottles
Official record key
drug-enforcement:D-0154-2017

Official wording

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

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

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility