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
Reported: December 7, 2016 Initiated: October 5, 2016 #D-0154-2017
Product Description
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
Details
- Recalling Firm
- Par Pharmaceutical, Inc.
- Units Affected
- a) 182,856 bottles; b) 59,448 bottles
- Distribution
- Nationwide
- Location
- Chestnut Ridge, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Par Pharmaceutical, Inc.. Units affected: a) 182,856 bottles; b) 59,448 bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 7, 2016. Severity: Moderate. Recall number: D-0154-2017.
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