B-Complex for Injection Recalled Due to Lack of Sterility Assurance
GenoGenix LLC is recalling all lots of B-Complex for Injection due to lack of assurance that the products meet sterility standards. The recall affects products 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 FDA Class II recall involves a documented deficiency in sterility assurance for injectable pharmaceutical products, representing a significant risk of harm. No illnesses or injuries have been reported.
Plain-English summary
GenoGenix LLC is recalling all strengths and presentations of B-Complex for Injection, including products labeled as manufactured for Synergy Wellness. All lots currently within their expiration dates are included in the recall.
The FDA determined that these products lack assurance of sterility. Sterility assurance is a critical requirement for injectable medications to ensure product safety. The manufacturer was unable to provide adequate documentation demonstrating that the products meet established sterility standards.
The recalled B-Complex for Injection products were distributed nationwide throughout the United States.
The recalled product
- Product
- B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
- 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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