Why it was recalled
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0154-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 5, 2016
- FDA report date
- Dec 7, 2016
- Quantity
- a) 182,856 bottles; b) 59,448 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0154-2017, exactly as published.
Show all FDA fields
- City
- Chestnut Ridge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 75471
- Address
- 1 Ram Ridge Rd
- 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
- Postal code
- 10977-6714
- Report date
- Dec 7, 2016
- Product type
- Drugs
- Recall number
- D-0154-2017
- Classification
- Class II
- Recalling firm
- Par Pharmaceutical, Inc.
- Product quantity
- a) 182,856 bottles; b) 59,448 bottles
- Termination date
- Jun 18, 2018
- Reason for recall
- Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 5, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 25, 2016