Reconstitution XO Solution for Injection Recalled Due to Sterility Concerns
Reconstitution XO Solution for Injection is being recalled nationwide due to lack of assurance of sterility in the manufacturing process.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with a sterility assurance failure. No illnesses or injuries have been reported in the source, making this a theoretical risk-of-harm scenario.
Plain-English summary
Reconstitution XO Solution for Injection is being recalled nationwide by GenoGenix LLC. The product is manufactured and distributed in multiple presentations, including versions labeled for CELIA Health, Extension Health, and Medical Health Institute (MHI), with exosome concentrations of 5%, 10%, and 20% in vial sizes ranging from 2 mL to 10 mL.
The recall was issued because the manufacturer cannot assure that the product meets required sterility standards. Injectable pharmaceutical products must be sterile to prevent serious infections.
All lots of the product currently within their expiration date are affected by this recall. Patients, healthcare providers, and facilities should discontinue use and contact their supplier. Any unused product should be returned to the manufacturer or disposed of according to proper pharmaceutical waste protocols.
The recalled product
- Product
- Reconstitution XO 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 CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes,
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
- Hazard
- sterility-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
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