B12 Hydroxocobalamin Injectable Drug Recalled Nationwide for Sterility Assurance
GenoGenix LLC recalls B12 Hydroxocobalamin for Injection nationwide due to lack of assurance of sterility. The injectable pharmaceutical is affected in all lots currently within expiration.
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 a Class II recall of an injectable drug for lack of assurance of sterility. No illnesses or injuries have been reported, but an injectable medication with potential microbial contamination represents a high-risk product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
GenoGenix LLC is recalling all B12 Hydroxocobalamin for Injection across all strengths and presentations. The injectable medication was distributed nationwide in the United States.
The recall was issued due to lack of assurance of sterility. This means the manufacturer cannot confirm that the product is free from contamination by bacteria or other microorganisms.
This recall affects all lots of the product that remain within their expiration date. Healthcare facilities and patients who have received this medication are potentially affected.
Patients and healthcare providers should cease using this product immediately. Anyone who received this injection should consult with their healthcare provider about potential risks and recommended monitoring.
The recalled product
- Product
- B12 Hydroxocobalamin 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
- lack-of-sterility
- contamination
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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