Agency classClass IIOur severity:Severe FDA (Drugs)·D-0294-2020·Announced 2019-11-13

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 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 hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the provided text, the 'Lack of Assurance of Sterility' for an injectable product represents a significant risk of serious adverse health consequences, aligning with the Severe classification for Class II recalls involving potential for serious harm.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, a prescription-only 5ml glass vial. The recall is being conducted because the product lacks assurance of sterility.

The affected product is identified by Lot # S05162019DT@04 with an expiration date of 8/16/19. The recall is classified as FDA Class II, indicating a situation where 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.

The product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product: S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Compounded Injectable
Hazard: sterility
infection

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 #: S05162019DT@04
Exp 8/16/19

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.

See all 100 products in this recall →

Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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