FDA Drug recall D-0035-2022
CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
- FDA Drug
- Class II
- terminated
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class II recall of CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx by First Royal Care, citing lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0035-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-13 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | First Royal Care |
| Distribution | AZ, CA, FL, MN, MT, TX, UT |
Product
CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
Reason
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Identifiers
| code_info | all lots within expiry |
|---|
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-0035-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.