L-Arginine HCl for Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling L-Arginine HCl for Injection due to lack of sterility assurance. The recall affects all strengths and presentations 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: FDA Class II drug recall with no reported illnesses or injuries. The hazard is a manufacturing control issue (lack of sterility assurance) that is potential rather than confirmed harm.
Plain-English summary
L-Arginine HCl for Injection manufactured by GenoGenix LLC is being recalled from the U.S. market. The recall includes all strengths and presentations of this injectable product.
The recall has been initiated due to a lack of assurance of sterility. This is a manufacturing and quality control issue that means the manufacturer cannot guarantee the product meets required sterility standards.
The product was distributed nationwide across the United States. The recall affects all lots currently within their expiration date.
Consumers and healthcare providers who have this product should stop using it and consult with their healthcare provider for guidance. The product should not be dispensed or administered. Healthcare facilities should quarantine existing stock and follow proper disposal procedures in accordance with applicable regulations.
The recalled product
- Product
- L-Arginine HCl 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
- manufacturing-defect
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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