MIC Compounded Injection Recalled Due to Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling MIC 25/50/50MG/ML MDV injectable medication due to lack of assurance of sterility following an FDA inspection. Approximately 494 patients in seven states received prescriptions for the affected product.
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 an FDA Class II recall involving a sterility assurance defect in a compounded injectable product distributed to nearly 500 patients. Although no illnesses or injuries are reported in the source text, the hazard—potential microbial contamination of an injectable medication—is inherently high-risk and qualifies as a High severity recall under the rubric criterion for "risk-of-harm products where injury has not yet been reported."
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling MIC 25/50/50MG/ML MDV, a prescription injectable medication in multi-dose vial (MDV) form. The recall was initiated after an FDA inspection raised concerns about the facility's ability to assure the sterility of the compounded product.
The recalled product was distributed to approximately 494 patients and consumers who received prescriptions. Distribution was identified in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
Patients who have received prescriptions for this product should consult with their healthcare provider or pharmacist about their treatment options. Patients should not discontinue their medication without first speaking to their doctor, as doing so could be harmful. Healthcare providers and patients with questions should contact the recalling pharmacy or their healthcare provider.
All affected lots remain within their expiration dates at the time of this recall notice.
The recalled product
- Product
- MIC 25/50/50MG/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
- injectable-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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