MIC/B12A Injectable Compounded Drug Recall for Sterility Assurance
Red Mountain Compounding Pharmacy is recalling MIC/B12A 25/50/50MG/ML 1MG/ML MDV injectable medication because FDA inspection found the firm could not guarantee the sterility of the product. Approximately 494 patients across seven states received prescriptions for this medication.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard is lack of sterility assurance in an injectable medication, which poses serious risk of infection and harm if administered to patients. Although no reported illnesses or deaths are stated in the source text, injectable products with sterility defects represent a significant potential for serious injury; this meets the threshold for a Severe rating per the rubric criterion for FDA Class II recalls with significant risk of harm.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling all lots of MIC/B12A 25/50/50MG/ML 1MG/ML MDV, a multi-dose vial (MDV) injectable medication. The recall was initiated after an FDA inspection identified concerns that the manufacturer lacked adequate assurance of sterility for this compounded drug product.
Approximately 494 patients and consumers received prescriptions for this medication. These individuals are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
Non-sterile injectable medications can pose serious health risks if administered to patients. Consumers who received this medication should contact their healthcare provider immediately to discuss the recall and determine whether any adverse effects have occurred. Healthcare providers should notify patients of the recall and advise them not to use any remaining doses of this product.
The recalled product
- Product
- MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- contamination-risk
- infection-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 in 7 states:
- AZ
- CA
- FL
- MN
- MT
- TX
- UT
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