Agency classClass IIOur severity:Severe FDA (Drugs)·D-0252-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-TEST CYP Vials Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP 100mg/ml vials because the FDA identified 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues) are categorized as Severe.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-TEST CYP 100mg/ml in Ethyl Oleate Oil. The product is available in 5ml and 10ml glass vials and is prescribed only. The recall covers 13 vials in total across four specific lot numbers: S02132019DT@02, S04092019DT@05, S06122019DH@35, and S06172019DH@04.

The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microorganisms, which poses a potential risk to patients. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide in the USA. Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on whether to stop using the product and how to return it.

The recalled product

Product: S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red Mountain Compounding Rx
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Compounded Medication
Hazard: sterility

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 (8)

Lot #:a) S02132019DT@02
Exp 8/13/19
b) S04092019DT@05
Exp 10/9/19
S06122019DH@35
Exp 12/12/19
S06172019DH@04
Exp 12/17/19

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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Same hazard · sterility