MIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling MIT/B12 25/50/50MG/ML 1MG/ML multidose vials due to FDA inspection findings that raised concerns about the lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II drug recall involving a sterility assurance deficiency in an injectable medication. Although no hospitalizations or illnesses are reported in the source text, lack of sterility in compounded injectables carries significant risk of harm and meets the FDA Class II threshold for severity score 4.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling MIT/B12 25/50/50MG/ML 1MG/ML multidose vials (prescription only). The recall is due to lack of assurance of sterility, as identified during an FDA inspection.
The affected product was distributed to approximately 494 patients who received prescriptions located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots within their expiration dates are included in this recall.
Patients who have received this product should contact their healthcare provider or dispensing pharmacy for guidance. Sterility assurance issues in injectable medications are serious concerns that can potentially affect patient safety.
The recalled product
- Product
- MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
- Category
- Drug — Compounded 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
Part of a larger recall action
This product is one of 40 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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