Hydroxocobalamin B12 injection recalled across all lots for sterility assurance
GenoGenix is recalling B12 Hydroxocobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
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: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in an injectable creates an infection risk, and no injuries are reported.
Plain-English summary
B12 Hydroxocobalamin for Injection, in all strengths and presentations, from GenoGenix, LLC of Boca Raton, Florida, is being recalled for lack of assurance of sterility.
The recall covers 25 units across all lots within expiry, distributed nationwide in the United States. The FDA has classified the recall as Class II.
Sterility matters for an injectable because the product is administered directly into the body. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Healthcare providers and patients holding the product should stop using it and contact the firm or their prescriber.
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
- sterility-assurance
- infection-risk
- injectable
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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