Regener-Eyes Recall Announcement Silent Regarding Unresolved Drug Adulteration Issues
On December 17, 2024 Regenerative Processing Plant LLC, the manufacturer of Regener-Eyes eye drops, announced a voluntary manufacturer recall through unofficial channels. A December 3, 2024 press release also referred to a recall. Both statements indicated that the purpose of the recall is to remove eye drops packaged in bottles without backflow prevention (multi-dose preservative free (MDPF) droppers) from the market.
All unexpired products manufactured prior to FDA inspection recalled
Recalls apply to products that are within expiration date. Regener-Eyes drops are labelled as having a 2 year shelf life, although the company has no data to support this according to the FDA’s August 16, 2024 Warning Letter.
The recall instruction letter to eye care providers includes a list of recalled products, lot numbers and expiration dates. If the expiration date is 12/20/2024, then the manufacturing date would be 12/21/2022. Regener-Eyes Lite's latest recalled manufacturing date is June 13, 2023 and Regener-Eyes Pro's is May 26, 2023. Regenerative Processing Plant was inspected by the FDA beginning on June 20, 2023. Thus, it appears that the entire within-expiration inventory manufactured prior to the FDA inspection is recalled.
Newly manufactured Regener-Eyes products adulterated per FDA
The company switched to an MDPF bottle, which they launched on September 25, 2024. Various press releases and trade journal articles have implied that this satisfied the FDA's concern regarding product sterility. This is incorrect.
From a patient safety perspective, the most important section of the FDA Warning Letter is headed Current Good Manufacturing Practice (CGMP) Violations. In this section, and in the inspection report Form 483, the agency provides extensive evidence that Regenerative Processing Plant cannot control its manufacturing processes sufficiently to ensure that its raw ingredients are pure, and that its eye drops are sterile before they are used. The FDA details the company's persistent inability or refusal to achieve CGMP in the Warning Letter under Corrective Actions.
It is unlikely, bordering on impossible, that Regenerative Processing Plant corrected its CGMP violations between August 16, 2024 (the date of the FDA Warning Letter) and September 25, 2024 (the launch of the MDPF bottle). It had not managed to do so in the preceding 14 months. Its newly manufactured eye drops in MDPF bottles are therefore still considered adulterated.
Backflow prevention bottle announcements distract from key safety issues
The new MPDF dropper has allowed Regener-Eyes to recall eye drops under the guise of exchanging them for a safer bottle. However, an MDPF dropper will not protect consumers from serious harm due to bacteria or fungus in eye drops prior to first use. Regenerative Processing Plant has been silent regarding its unresolved CGMP violations.
The Dry Eye Foundation continues to recommend against the use of Regener-Eyes Lite and Regener-Eyes Pro, regardless of bottle type or manufacture date.