FDA recall D-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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-10-05

Report date

2016-12-07

Termination date

2018-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chestnut Ridge, NY, United States

Primary source

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