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Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, G...

FDA Recall #D-0074-2026 — Class II — July 30, 2025

Recall #D-0074-2026 Date: July 30, 2025 Classification: Class II Status: Ongoing

Product Description

Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billion per vial, 8mL of solution in 10mL vial.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

GenoGenix LLC — Boca Raton, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

US Nationwide.

Code Information

All lots within expiry.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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