Red Mountain Compounding Pharmacy Recalls S-MIC Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-MIC 25/50/50mg/ml Cyanocobalamin 1mg/ml MDV 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 rubric specifies that FDA Class II recalls with potential for serious health consequences (such as sterility issues in injectable drugs) are rated as Severe.
Plain-English summary
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, is recalling S-MIC 25/50/50mg/ml Cyanocobalamin 1mg/ml MDV Solution, a prescription-only medication packaged in 30ml glass vials. The recall was initiated due to a lack of assurance of sterility in the product.
The affected product is identified by Lot # S05242019DT@10 and has an expiration date of 08/31/2019. The recall is classified as FDA Class II. The source text does not specify the geographic distribution of the affected units or the number of vials involved.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- S-MIC 25/50/50MG/ML CYANO 1MG/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 (2)
- Lot #: S05242019DT@10
- Exp 08/31/2019
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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