Recalls / Class II
Class IID-0282-2020
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.
- Affected lot / code info
- 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;
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6828 E Brown Rd Ste 101, N/A, Mesa, Arizona 85207-3761
Distribution
- Quantity
- 91 x 5, 10, 13 ML glass vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-08-12
- FDA classified
- 2019-11-05
- Posted by FDA
- 2019-11-13
- Terminated
- 2023-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0282-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.