FDA Drug recall D-1065-2018
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only
- FDA Drug
- Class II
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class II recall of Ropivacaine HCl 2 mg/mL 550 mL. Rx Only by Guardian Pharmacy Services, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1065-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-17 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Guardian Pharmacy Services |
| Distribution | TX |
Product
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Reason
Lack of sterility assurance.
Identifiers
| code_info | Lots: 59086:42 Use By: 05/24/2018; 59163:42 Use By: 05/30/2018 |
|---|
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-1065-2018%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.