Regener-Eyes Recall
Unofficial recall
A few days ago, Regener-Eyes LLC unofficially announced that it was recalling its preservative-free eye drops packaged in a standard bottle without a multi-dose preservative free (MDPF) dropper. The company has not yet officially recalled its products (see https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts).
Due to the informal nature of the recall, customary recall information that patients need to ensure their own safety was not provided: product names, manufacture dates, lot numbers, expiration dates, and photographs that help identify improperly packaged eye drops.
Ongoing safety concerns
The FDA Warning Letter to Regenerative Processing Plant on August 16, 2024 cited the company for multiple violations of sterile manufacturing standards. During pre-production testing, some test bottles were contaminated with bacteria. The company failed to properly identify and correct the source of contamination and failed to ensure, through repeat testing, that the manufacturing contamination problem had been resolved. This means that Regener-Eyes eye drops may be contaminated with bacteria or fungus before they are placed in the bottle. Further, Regenerative Processing Plant failed to keep basic records related to production of each batch of its products. The company has not provided lot numbers for eye drops produced in a potentially unsterile fashion, and may not know them.
Regener-Eyes is aggressively advertising its new MDPF bottle. Bottles with backflow prevention devices, which have been in common use for OTC products for many years, are intended to protect against contamination after the bottle is opened and used. They cannot protect patients against contamination that occurs during manufacture. Therefore, the switch to an MDPF bottle does not change Dry Eye Foundation's recommendations regarding Regener-Eyes eye drops.
What should I do?
If you have any unused or partially used Regener-Eyes brand products Dry Eye Foundation recommends the following:
Discontinue use and store product in a safe place that is cool, dry and dark (do not discard)
Ask your eye care professional for an alternative product recommendation
Keep records of any Regener-Eyes purchases, including receipts and photographs of bottles and outer packaging with lots, expiration dates and any other identifying information; keep the boxes if you have them
Contact the FDA with any questions at 800-835-4709 option 1 or ocod@fda.hhs.gov.
Once Regener-Eyes has fully addressed the FDA's concerns as set out in its inspection report and Warning Letter, the FDA may issue a Close Out Letter. Until Regenerative Processing Plant LLC receives an FDA Close Out Letter, patients and eye care providers cannot be confident that its products are sterile before first use.