The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0297-2020·Announced 2019-11-13

Red Mountain Compounding Pharmacy Recalls S-TRIMIX Injections for Sterility Concerns

First Royal Care Co. LLC is recalling S-TRIMIX compounded injections nationwide 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 involves a lack of assurance of sterility in an injectable drug, which poses a risk of serious adverse health consequences such as infection.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-TRIMIX compounded injections in various strengths. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected products are prescription-only 5ml glass vials distributed nationwide in the United States. The recall covers multiple lot numbers and expiration dates, ranging from August 2019 to September 2019.

Consumers who have purchased or received these products should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML)…
Manufacturer
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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 (20)

  • Lot #:a) S07162019DH@07
  • EXP. 9/16/19 b) S06242019DH@01
  • EXP 8/24/19
  • S07102019DT@15
  • EXP. 9/20/19
  • S07252019DH@03
  • EXP. 9/25/19
  • S07312019DH@13
  • EXP. 9/31/19 c) S07102019DT@03
  • EXP. 9/10/19 d) S07262019DH@01
  • EXP. 9/26/19
  • S07232019DH@07
  • EXP. 9/23/19 e) S06262019DH@05
  • EXP. 8/26/19
  • S07132019DT@06
  • EXP. 9/13/19 f) S06162019DH@12
  • EXP. 8/16/19 g) S06252019DT@06
  • EXP. 8/25/19
  • S07032019DT@04
  • EXP. 9/3/19

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 →

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

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