Important Safety Notice: Unauthorized Saypha Products Detected in the Canadian Market

Renellence Inc., the exclusive authorized distributor of Croma-Pharma GmbH's Saypha dermal filler portfolio in Canada, is issuing this notice following the conclusion of a Health Canada investigation into unauthorized Saypha products circulating in the Canadian market.

Health Canada's Border Operations Program identified a shipment of Croma-Pharma Saypha products, Saypha Volume and Saypha Volume Plus with Lidocaine, exported from Italy, imported into Canada by an unauthorized party. The investigation confirmed that the device identifiers on these units do not correspond to those licensed for the Canadian market, and that the shipment originated outside Renellence's authorized supply chain. Renellence cooperated fully with Health Canada throughout the investigation, and Croma-Pharma has confirmed the findings.

A Saypha product sourced outside Renellence's authorized supply chain carries no traceability. That means:

• No confirmed cold-chain documentation from manufacturer to clinic
• No batch or lot verification against Croma-Pharma's records
• No assurance against mishandling, improper storage, or tampering
• No recourse in the event of a product-related adverse event
  

Neither Renellence Inc. nor Croma-Pharma GmbH can guarantee the quality, safety, or integrity of any Saypha product not purchased through Renellence's authorized Canadian channel.

What You Should Do:

• Purchase Saypha products exclusively through Renellence Inc.
• If you've recently received Saypha from an unfamiliar or discounted source, contact us immediately at admin@renellence.com before using it.
• If you're aware of other parties claiming to offer Saypha in Canada, report it to us and to Health Canada.

Protecting your patients starts with knowing exactly where your products come from. Renellence exists to ensure that every unit of Saypha reaching a Canadian clinic has a complete, verified chain of custody from Croma-Pharma's facility to your hands.

For questions or to verify your supply chain, contact us at admin@renellence.com or visit renellence.com.