FDA Drug recall D-0279-2020
S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml 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-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml 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-0279-2020 |
| 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-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #:a) S04162019DH@04, Exp 8/16/19;S04182019DT@11, Exp 8/18/19; S04302019DT@08, Exp 8/30/19; S05292019DT@11, Exp 9/2…Lot #:a) S04162019DH@04, Exp 8/16/19;S04182019DT@11, Exp 8/18/19; S04302019DT@08, Exp 8/30/19; S05292019DT@11, Exp 9/29/19; S06092019DH@08, Exp 10/9/19, S06252019DH@15, Exp 10/25/19; S07022019DH@10, Exp 11/2/19, S07292019DH@11, Exp 11/29/19; b) S06032019DT@02, Exp 10/3/19; S07232019DH@03, Exp 11/23/19 |
|---|
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-0279-2020%22
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