Red Mountain Compounding Recalls S-MIC 25/50/50 B12A Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC 25/50/50 B12A 5mg/ml solution due to a lack of assurance of sterility.
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: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-MIC 25/50/50 B12A 5mg/ml MDV Soln. The product is a prescription-only medication packaged in 30ml glass vials. The recall involves seven 30ml glass vials per unit.
The recall was initiated due to a lack of assurance of sterility. The affected lots include S03302019DT@02, S05062019DH@12, S06162019DH@13, and S07132019DT@05. These products were distributed nationwide in the USA.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be discontinued and returned to the pharmacy or manufacturer for disposal or credit.
The recalled product
- Product
- S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, 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 (8)
- Lot #: S03302019DT@02
- Exp 09/30/2019
- S05062019DH@12
- Exp 11/06/2019
- S06162019DH@13
- Exp 12/16/2019
- S07132019DT@05
- Exp 01/13/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 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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