Manufacturer Voluntary Product Withdrawal - Similasan
Emerson Healthcare LLC, suppliers of Similasan products, has announced a voluntary withdrawal of the following items:
- Similasan – Stye Eye Relief 10ml | UPC 0 94841 30054 2
- Similasan – Pink Eye Relief 10ml | UPC 0 94841 30034 4
- Similasan – Dry Eye Relief 10ml | UPC 0 94841 30014 6
- Similasan – Complete Eye Relief 10ml | UPC 0 94841 30060 3
- Similasan – Allergy Eye Relief 10ml | UPC 0 94841 30024 5
- Similasan – Computer Eye Relief 10ml | UPC 0 94841 30047 4
- Similasan – Red Eye Relief 10ml | UPC 0 94841 30063 4
- Similasan – Dry Eye Relief – Single Use 20ct | UPC 0 94841 30013 9
- Similasan – Dry Eye Nighttime Gel 10ml | UPC 0 94841 30016 0
- Similasan – Allergy Eye Relief Single Use 20ct | UPC 0 94841 30023 8
- Similasan – Kids Allergy Eye Relief 10ml | UPC 0 94841 30035 1
- Similasan – Kids Pink Eye Relief 10ml | UPC 0 94841 30026 9
From the company:
“To Our Valued Partners,
As you know, eight ophthalmic companies, including Similasan, recently received warning letters from the FDA which brought up several concerns that the FDA had about the marketing and manufacturing of homeopathic eye drops and the safety of one of the preservatives used in their manufacture, silver sulfate.
Each company has 15 business days to reply to the FDA to indicate how they intend to respond to their respective letters. Similasan’s US leadership team has been in discussions with our retail partners, our manufacturing centers, and our shareholders as we develop an appropriate response.
Pending resolution of the FDA concerns, we have voluntarily suspended the sale and distribution of all Similasan eye drop products to US retailers. We are cooperating with the FDA to quickly resolve this matter.
Our ear drops and other ear relief products are not affected by the FDA’s action, and we want to thank you for your continued support of them and of the Similasan brand as we work towards a solution with the FDA. We will continue to update you as we have more clarity.
Sincerely, Dan Quail President, North America Similasan USA”
Further FAQs regarding this matter have been posted to https://www.similasanusa.com/similasan-statement-regarding-fda-warning-letter?gclid=EAIaIQobChMIjPmGitqCggMVxyatBh0swwy-EAAYASAAEgKa8_D_BwE
A copy of the FDA warning letter may be viewed online here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/similasan-ag-658878-09112023
Consumer Instructions:
There are no specific actions consumers need to take at this time. The North Coast Co-op is providing notification of this voluntary withdrawal out of an abundance of caution and as a courtesy to NCC membership. There are no reported consumer safety issues with the specified products, and Similasan is working with the FDA to resolve issues raised in the FDA warning letter.
Notifications of this withdrawal will be posted at the point of sale as well as at our Customer Service desks. These products were available in both our Arcata and Eureka stores, and the withdrawn items were present on the shelf.
Customers with any questions or concerns about this matter may call NCC Merchandising at 707-822-5947ext.244 or 707-443-6027 ext.443.
NCC Arcata NCC Eureka
8th & I Streets 4th & B Streets
Arcata, CA 95521 Eureka, CA 9550
(707) 822-5947 (707) 822-6027