Lipo MIC +B12 Methylcobalamin Injection Recalled Over Sterility
GenoGenix LLC is recalling Lipo MIC +B12 Methylcobalamin for Injection nationwide due to lack of assurance of sterility. Consumers should discontinue use and contact their healthcare provider.
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 recall involving a risk-of-harm product (injectable pharmaceutical) with identified sterility deficiency. No illnesses or injuries have been reported, making this a precautionary recall based on process controls rather than documented patient harm.
Plain-English summary
GenoGenix LLC is recalling all strengths and presentations of Lipo MIC +B12 Methylcobalamin for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Sterility assurance is critical for injectable pharmaceutical products.
Consumers who have obtained this product should discontinue use and contact their healthcare provider. Any adverse events should be reported to the FDA.
The recalled product
- Product
- Lipo MIC +B12 Methylcobalamin 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-failure
- 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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