Bacteriostatic Water for Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling all lots of Bacteriostatic Water for Injection nationwide due to lack of assurance of sterility, a serious concern for any injectable product.
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 recalls address products with reasonable possibility of serious adverse health consequences. This recall involves a sterile injectable product with unassured sterility; no illnesses or injuries have been reported, but the potential for serious infection from non-sterile injectables justifies a high severity rating.
Plain-English summary
GenoGenix LLC is recalling all lots of Bacteriostatic Water for Injection, all strengths and presentations, that are within expiry. The product is distributed nationwide. Some products are also labeled as manufactured for CELIA Health, Extension Health, and Medical Health Institute.
The reason for this recall is a lack of assurance of sterility. Bacteriostatic water is intended for use as a sterile injectable product. Failure to ensure sterility poses a serious risk of infection if the product is used for injections.
Healthcare facilities, medical clinics, and other settings where injectable products are used may have received this product and should verify if they are using affected lots.
Persons and healthcare providers who have unused quantities of this product should discontinue use.
The recalled product
- Product
- Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute
- Manufacturer
- GenoGenix LLC
- 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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