Magnesium Chloride for Injection Recalled for Sterility Assurance Issues
GenoGenix is recalling Magnesium Chloride for Injection (all strengths and presentations) due to lack of sterility assurance. Approximately 430 units were distributed nationwide.
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 a risk-of-harm injectable drug product with lacking sterility assurance, creating potential for serious infection if contamination exists. No illnesses, injuries, or hospitalizations have been reported, warranting High severity under the rubric's criteria for risk-of-harm products without reported injury.
Plain-English summary
GenoGenix, LLC is recalling Magnesium Chloride for Injection in all strengths and presentations. Approximately 430 units have been distributed nationwide.
The recall is due to lack of assurance of sterility. Sterility is critical for injectable medications, as non-sterile injectables carry the risk of serious infection and other serious adverse health consequences.
All lots of the product currently within their expiration dates are affected by this recall. Healthcare providers and facilities that have received this product should cease use and distribution immediately.
The recalled product
- Product
- Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- infection-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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