FDA Recalls pH Buffered Reconstitution Solution for Sterility Assurance Failure
GenoGenix LLC is recalling pH Buffered Reconstitution Solution for Injection nationwide due to lack of assurance of sterility. All lots within expiration dates are affected.
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: FDA Class II recall for a sterility defect in a sterile injectable product. No illnesses or injuries have been reported in the source material. The lack of sterility assurance presents a theoretical contamination risk, but without documented adverse events, this is classified as High severity per the rubric.
Plain-English summary
GenoGenix LLC is recalling pH Buffered Reconstitution Solution for Injection (all strengths and presentations) because the company cannot assure that the product meets sterility requirements. The product is distributed nationwide.
All lots of the product currently within their expiration dates are included in the recall. The manufacturer is GenoGenix LLC, located in Boca Raton, Florida. The product is also labeled as manufactured for Medical Health Institute (MHI).
Patients and healthcare providers who have this product should contact their healthcare provider for guidance on appropriate next steps. The product should not be used.
The recalled product
- Product
- pH Buffered 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 Medical Health Institute (MHI), 10mL.
- Manufacturer
- GenoGenix LLC
- Hazard
- sterility-failure
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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