Red Mountain Compounding Recalls S-TRIMIX Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.
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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable drug corresponds to a severity score of 4 (Severe), as it poses a risk of serious injury or hospitalization.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vials. The recall is being conducted because the product lacks assurance of sterility.
The affected product consists of 3x5ml glass vials. The specific lot numbers involved are S06092019DH@07 (Exp 8/9/19), S06112019DH@03 (Exp 8/11/19), and S06122019DH@01 (Exp 8/12/19). The product was distributed nationwide in the USA.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx
- Category
- Drug — Injectable
- Hazard
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 (6)
- Lot #:S06092019DH@07
- Exp 8/9/19
- S06112019DH@03
- Exp 8/11/19
- S06122019DH@01
- Exp 8/12/19
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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