New Eye Drop Safety flags
Dry Eye Foundation has added new red flags to various eye drops in the Eye Drop Safety Database due to manufacturing compliance issues with sterility implications:
- Advanced Eye Relief Dry Eye
- Soothe PF
- Biotrue Hydration Boost PF (bottle, not vials)
- Blink Tears (preserved bottle)
- Blink Triple Care (preserved and preservative-free bottle)
- Blink Boost PF
- Blink Nourish PF
The most recent FDA inspection at the Greenville, SC facility where each of these products are manufactured was classified Official Action Indicated (OAI). OAI is the worst of 3 possible inspection outcomes.
Biotrue Hydration Boost was specifically named in the FDA inspection report (obtained through a Freedom of Information Act request). Other products were separately confirmed to be manufactured at the same facility. We also noted that an eye wash (exact name unclear) was cited in the inspection report.
DES pausing sales of some products
We have a zero tolerance policy at the Dry Eye Shop for products with evidence of serious failures to uphold proper standards of sterility in their eye drop manufacturing.
We have chosen to pause sales of all of the products flagged by the Foundation from our stock and discontinue sales, and in addition, similar products that we believe (but have not yet formally confirmed) are made at the same facility. We will seek further information from Bausch & Lomb.
I want to emphasize that there are NO recalls or FDA warnings about these products. We will not be refunding them. We are simply stopping sales until such time as current compliance information becomes available for the manufacturing facility. If you have unopened stock of these products, we can swap them out or provide in-store credit if you wish.
Here are the products that we are pausing:
- Blink Triple Care PF (bottle)
- Blink Boost PF (bottle)
- Biotrue Hydration Boost PF (bottles, NOT vials - the vials are made at Bausch's Tampa facility which had good inspection results)
- Biotrue Hydration Boost PF Contacts (bottle)
- Soothe PF (vials)
5 comments
Do you know when and if Freshkote drops will be back on the mkt in the mean time what drops have similar ingredients…thanks so much for you much needed service sure appreciate you 👍
Thank you SO much for keeping us informed! Is Soothe lubricant eye ointment (nighttime, PF) dry eye therapy part of the products manufactured at the facility in Greenville, SC?
Your integrity, as demonstrated by this decision, is why you have my deep respect. Thank you for your commitment to the dry eye community.
Thank you very much for your diligence in monitoring the safety of products!!!
I greatly appreciate the information.
Thank you for keeping your customers informed and being proactive