Proline for Injection recalled for lack of sterility assurance
GenoGenix LLC is recalling all lots of Proline for Injection due to lack of assurance of sterility. Patients should contact their healthcare provider to discuss treatment options.
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 for lack of sterility assurance on an injectable drug with no reported illnesses or injuries. The hazard qualifies as a risk-of-harm product where injury has not yet been reported, placing it in the High severity category per the rubric.
Plain-English summary
GenoGenix LLC is recalling all strengths and presentations of Proline for Injection nationwide due to lack of assurance of sterility.
The manufacturer was unable to confirm that all manufacturing processes met sterility standards required for injectable medications. This quality assurance failure affects all lots of the product currently within expiry.
Proline for Injection is distributed nationwide. The recall affects patients who may have received this medication. No illnesses or injuries have been reported in connection with this recall.
Patients who have received Proline for Injection should contact their healthcare provider immediately to discuss their treatment options and whether they may have received affected product. Healthcare providers should return recalled product to the manufacturer.
The recalled product
- Product
- Proline 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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