Skip to content
Recall Observatory FDA recall evidence

Drug 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.

D-0282-2020

August 12, 2019

Class II

Product summary

Firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Event
Event 83669
Status
Terminated
Classification
Class II
Quantity
91 x 5, 10, 13 ML glass vials
Official record key
drug-enforcement:D-0282-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 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, Exp 11/2/19; S5212019DH@14, Exp 11/21/19; S06032019DT@07, Exp 12/3/19; S06122019DT@08, Exp 12/12/19; S07162019DT@13, Exp 1/16/20; S07262019DH@05, Exp 1/26/20; S05212019DH@14, Exp 8/21/19;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility