ATTENTION: Immediate product recall notice for two Regener-Eyes products

All eye care providers should be alert to a voluntary recall issued on Dec. 17 by Regenerative Processing Plant, LLC, for the following products: 

• Regener-Eyes Professional® (NDC: 82305-003-01) 
• Regener-Eyes Lite® (NDC: 82305-006-01) 

The company has indicated that a voluntary recall is necessary due to a packaging integrity issue with the eyedropper dispensing applicators, specifically, their lack of a backflow prevention mechanism. This poses a risk for potential illness and sickness, the company says, as a backflow prevention mechanism helps maintain product sterility and ensures user safety. 

Required actions 

1. Examine Inventory. Identify and quarantine affected products on Table I and II of the official recall form for lot numbers.
2. Notify Customers. Please alert patients and include a copy of Regener-Eyes recall notification letter.
3. Destroy Affected Products. Please eliminate these products according to local regulations and complete the official recall form to describe actions taken. 

For further information, please contact the company’s recall coordinator.

Federal notice 

The U.S. Food and Drug Administration (FDA) issued a warning letter to Regenerative Processing Plant, LLC, on Aug. 16, that called attention to manufacturing violations for finished pharmaceuticals, including the contamination risk due to a lack of backflow prevention device. Additionally, the Regener-Eyes® PRO and Regener-Eyes® LITE products were deemed unapproved new drugs introduced or delivered for introduction into interstate commerce, while the Regener-Eyes® Professional and Regener-Eyes® LITE products were also misbranded in violation of federal statutes: 

• 505(a) of the FD&C Act [21 U.S.C. § 355(a)] 
• 502(a) and 502(ee) of the FD&C Act [21 U.S.C. §§ 352(a) and (d)] 

Introduction or delivery for introduction of these products into interstate commerce is prohibited by federal statute, the FDA notice states. Further details can be found within the FDA notice itself.