Sterile Saline Reconstitution Solution Recalled Due to Lack of Sterility Assurance
GenoGenix LLC is recalling all lots of Sterile Saline Reconstitution Solution for Injection nationwide due to lack of sterility assurance. No illnesses or injuries have been reported.
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 lack of sterility assurance in injectable product. No illnesses or injuries are mentioned in the source, and the hazard is theoretical rather than demonstrated, limiting severity to High per the rubric.
Plain-English summary
GenoGenix LLC is recalling all lots of Sterile Saline Reconstitution Solution for Injection at all strengths and presentations distributed nationwide. All affected lots are currently within their expiry dates.
The recall was issued because the product lacks assurance of sterility. Sterile injectable solutions must maintain strict sterility standards during manufacturing and storage.
This recall affects healthcare facilities and medical providers who may have this product in use. No illnesses or injuries have been reported at this time.
Healthcare providers should discontinue use of affected product and contact GenoGenix LLC for instructions on product replacement and return.
The recalled product
- Product
- Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Sterile Injectable
- Hazard
- 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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