MIC/B12A/B6 Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling MIC/B12A/B6 injectable medication because FDA inspection identified concerns about sterility assurance. The recall affects 494 patients across seven states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall, which is typically classified as Moderate severity. The source does not report any illnesses, hospitalizations, injuries, or deaths linked to the product; the hazard is a sterility assurance concern identified during inspection without documented patient harm.
Plain-English summary
Red Mountain Compounding Pharmacy (First Royal Care Co. LLC) is recalling MIC/B12A/B6 15/50/100 5MG/50MG/ML multiple-dose vials (MDV) for injection use due to lack of assurance of sterility.
An FDA inspection raised sterility assurance concerns regarding the product. All lots within their expiration date are included in this recall.
The recall affects 494 patients and consumers who received prescriptions for this medication. These patients are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
Patients currently using this medication should contact their healthcare provider or pharmacist before discontinuing use to discuss treatment options and next steps.
The recalled product
- Product
- MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- microbial-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 in 7 states:
- AZ
- CA
- FL
- MN
- MT
- TX
- UT
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