FDA Drug recall D-0946-2018
fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL…
- FDA Drug
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL… by Avella Of Deer Valley Store 38, citing lack of Assurance of Sterility: Potential leakage of bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0946-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-12 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avella Of Deer Valley Store 38 |
| Distribution | US |
Product
fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-278-86
Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Identifiers
| code_info | Lot #: 5/14/18 1012 172-27886Y, BUD 6/28/2018. |
|---|
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-0946-2018%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.