FDA Drug recall D-0205-2020
S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, 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-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, 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-0205-2020 |
| 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-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: S03142019DT@09, Exp 9/14/19; S05052019DH@04, Exp 11/5/19; S06192019DT@03, Exp 12/19/19; S06262019DT@12, Exp 12/26/19 |
|---|
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-0205-2020%22
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