Ascorbic Acid Injection Recalled Due to Sterility Assurance Failure
GenoGenix LLC is recalling all lots of Ascorbic Acid (Vitamin C) for Injection due to lack of assurance of sterility. The recall affects approximately 1,550 units 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 an FDA Class II recall for lack of sterility assurance in an injectable pharmaceutical product. Injectable medications lacking sterility assurance represent a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
GenoGenix LLC is recalling Ascorbic Acid (Vitamin C) for Injection in all strengths and presentations. Approximately 1,550 units were distributed nationwide, and all lots are still within their expiration dates.
The recall is due to lack of assurance of sterility. Injectable pharmaceutical products must be manufactured under strict sterility controls to prevent microbial contamination, which could pose serious health risks to patients.
The affected product was distributed nationally. Healthcare providers and patients who received this medication should be aware of the recall and consult with their healthcare provider regarding any concerns about injections administered from recalled lots.
As of the recall announcement, no illnesses or injuries related to the product have been reported. Patients should not dispose of unused medication in household trash or water; disposal should follow local guidelines or utilize a medication take-back program.
The recalled product
- Product
- Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable Preparation
- Hazard
- lack-of-sterility
- contamination-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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