FDA Drug recall D-0204-2020
S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, 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-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, 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-0204-2020 |
| 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-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: S05132019DH@02, Exp 8/13/19; S05142019DT@05, Exp 8/14/19; S07032019DT@10, Exp 10/3/19; S07182019DH@01, Exp 10/18/19 |
|---|
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-0204-2020%22
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