L-Glutamine for Injection Recalled Due to Lack of Sterility Assurance
GenoGenix LLC is recalling all lots of L-Glutamine for Injection nationwide because the company cannot assure the product meets sterility requirements for safe injection.
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 drug product with lack of sterility assurance. No illnesses or injuries are reported in the source. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, which corresponds to a High severity score.
Plain-English summary
GenoGenix LLC is recalling all lots of L-Glutamine for Injection in all strengths and presentations distributed nationwide in the United States. The recall is due to a lack of assurance of sterility for the product.
L-Glutamine for Injection is administered directly into the body via injection. Products that lack assured sterility can pose a serious risk to patients who receive them.
Patients or healthcare providers who have received or are in possession of L-Glutamine for Injection should stop using the product. Consult with your healthcare provider if you have concerns about whether you may have received a recalled lot.
The recalled product
- Product
- L-Glutamine 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
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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