FDA-Drug2016-12-07Class II

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

Par Pharmaceutical, Inc.
Hazard

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

Sold states
Nationwide
Affected count
a) 182,856 bottles; b) 59,448 bottles
Manufactured in
1 Ram Ridge Rd, Chestnut Ridge, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0154-2017

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