Calcium Chloride for Injection Recalled Due to Sterility Concerns
GenoGenix LLC is recalling all lots of Calcium Chloride for Injection nationwide due to lack of sterility assurance. Patients should discontinue use and contact their healthcare provider.
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 medication with sterility concerns, representing a significant risk-of-harm product. No illnesses or injuries have been reported in the source text, so the score is limited to 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
GenoGenix LLC is recalling all lots of Calcium Chloride for Injection in all strengths and presentations due to lack of assurance of sterility. Calcium Chloride for Injection is administered directly into the bloodstream, and lack of sterility assurance poses a potential infection risk.
The recall covers all lots distributed nationwide in the United States. All recalled lots remain within their expiration dates at the time of this recall notification.
Patients and healthcare providers who have or use this product should discontinue use and contact their pharmacy or healthcare provider for guidance on replacement therapies or alternatives.
The recalled product
- Product
- Calcium 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 Medication
- Hazard
- sterility-failure
- 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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