GAC for Injection Recalled Due to Sterility Assurance Failure
GenoGenix LLC is recalling all lots of GAC for Injection due to lack of assurance of sterility. Patients should contact their healthcare provider regarding their medication.
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 FDA Class II recall involves lack of sterility assurance in an injectable drug product. With no reported illnesses or injuries, the hazard remains theoretical risk of harm, justifying a High severity rating per the rubric.
Plain-English summary
GenoGenix LLC is recalling all strengths and presentations of GAC for Injection distributed nationwide in the United States.
The recall is due to lack of assurance of sterility. This means the company cannot guarantee that the injectable product maintains the required sterility standards necessary for safe use.
The recall affects all lots currently within their expiration dates. Patients who have received this medication should contact their healthcare provider to discuss their medication status and determine if any follow-up care is needed.
The recalled product
- Product
- GAC 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
- sterility-assurance
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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