The Recall Desk
SevereFDA (Drugs)·D-0295-2020·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.

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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are categorized as Severe (Score 4), particularly when involving significant risks such as sterility issues in injectable drugs.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vials. The recall is due to a lack of assurance of sterility in the product.

The affected product is identified by Lot # S06092019DH@04 with an expiration date of 8/9/19. The recall number is D-0295-2020. The product was distributed nationwide in the USA.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx
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 #:S06092019DH@04
  • Exp 8/9/19

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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