Recalls / Class II
Class IID-0286-2020
Product
S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx
- Affected lot / code info
- Lot #: S02252019DH@07, Exp 8/25/19; S03202019DT@02, EXP, 8/25/19; S03212019DT@02, EXP, 9/21/19; S04232019DT@06, EXP, 10/23/19; S05232019DT@06, EXP, 11/23/19; S05152019DH@12, EXP, 11/15/19; S05242019DT@03, EXP, 11/24/19; 05152019DH@12, EXP, 11/15/19; S06262019DT@02, EXP, 12/26/19; S07032019DT@12, EXP, 1/3/20; S07132019DT@03, EXP, 1/13/20; S07162019DT@01, EXP, 1/16/20; S07262019DH@06, EXP, 1/26/20; S05152019DH@12, EXP, 11/15/19;
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
- 129x 5ml, 10ml, 13ml 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-0286-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.