Red Mountain Compounding Pharmacy Recalls S-TRIMIX Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the FDA determined there is a lack of assurance of sterility.
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, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) map to a severity score of 4 (Severe), as they are not Class I (Critical) but represent a significant risk.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, a prescription-only 5ml glass vial. The recall was initiated due to a lack of assurance of sterility in the product.
The affected product is identified by Lot # S06142019DH@01 with an expiration date of 8/14/19. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers who have this specific lot of S-TRIMIX should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Compounding Rx.
- Category
- Drug — Compounded 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 (2)
- Lot #: S06142019DH@01
- Exp 8/14/19
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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