Agency classClass IIOur severity:Severe FDA (Drugs)·D-0282-2020·Announced 2019-11-13

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

Red Mountain Compounding Pharmacy is recalling S-TEST CYP 25mg/ml vials 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile injectable medications.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, a prescription-only medication. The product is available in 5 ml, 10 ml, and 13 ml glass vials. The recall covers 91 vials distributed nationwide in the USA.

The recall was initiated due to a lack of assurance of sterility. The affected lots have expiration dates ranging from August 19, 2019, to January 26, 2020. Specific lot numbers include S02192019DH@14, S02282019DH@06, and S03142019DT@04, among others.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be discontinued and returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product: S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml glass vial, Red Mountain Compounding Rx.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Compounded Injectable
Hazard: lack-of-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 (20)

Lot #: S02192019DH@14
Exp 8/19/19
S02282019DH@06
Exp 8/28/19
S03142019DT@04
Exp 9/14/19
S03252019DH@03
Exp 9/25/19
S04102019DT@05
Exp 10/10/19
S05012019DT@03
Exp 11/1/19
S05022019DT@11
Exp 11/2/19
s05012019dt@09
S5212019DH@14
Exp 11/21/19
S06032019DT@07
Exp 12/3/19
S06122019DT@08

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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