FDA Drug recall D-0286-2020
S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx
- FDA Drug
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx by First Royal Care, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0286-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-12 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | First Royal Care |
| Distribution | US |
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
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: S02252019DH@07, Exp 8/25/19; S03202019DT@02, EXP, 8/25/19; S03212019DT@02, EXP, 9/21/19; S04232019DT@06, EXP…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0286-2020%22
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