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)
7 comments
Hi Beth! Just wanted to quickly mention that The Dry Eye Foundation has a website where you can look up eye drops by name and see if there are any current red flags or recalls on them. Check it out here: https://alerts.eyedropsafety.org/. If you have trouble finding the product there, let us know the exact full name of the drops and we can try to get some more information for you!
Hi: I use the Bausch and Lomb eye allergy itch relief (same ingredient as Pataday once a day). The box states these are a product of Italy. Are these okay?
I did toss my unopened box of the Soothe vials that I got at CVS out of an abundance of caution. Thanks for this information which is not readily available.
With my eye issues, the waves of recalls have really grown wearisome! I haven’t used any generics from the drugstores for years, but it seems like the major brands are not immune now.
Thanks again!
Hi Lori. We don’t have any information as to when Freshkote will be back on the market. We stopped carrying those a while ago and recently, there was a recall on all unexpired lots (more info here: https://www.eyedropsafety.org/news/blog/excelvision-recalls). One option that’s available with little ingredients is Eyeganics Organic Tear Drops (not sold here) and Oasis Tears PF is another great option! Hope this helps!
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 👍
Your integrity, as demonstrated by this decision, is why you have my deep respect. Thank you for your commitment to the dry eye community.