FDA Drug recall D-0214-2020
S-DMSO 100% (PF) STERILE SOLUTION
- FDA Drug
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of S-DMSO 100% (PF) STERILE SOLUTION by First Royal Care, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0214-2020 |
| 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-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #:a) S04242019DT@15, Exp 10/24/19; S05012019DH@03, Exp 11/1/19; S05072019DT@10, Exp 11/7/19; S05072019DT@12, Exp 1…Lot #:a) S04242019DT@15, Exp 10/24/19; S05012019DH@03, Exp 11/1/19; S05072019DT@10, Exp 11/7/19; S05072019DT@12, Exp 11/7/19; S06202019DT@03, Exp 12/20/19; S06202019DT@04, Exp 12/20/19; S07222019DH@05, Exp 07/22/2019 b) S06272019DT@06, Exp 12/27/19; |
|---|
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-0214-2020%22
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