FDA Drug recall D-0333-2019
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 m…
- FDA Drug
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 m… by Pharmedium Services, citing sub-potent.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0333-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-05 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharmedium Services |
| Distribution | US |
Product
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
Reason
Sub-potent
Identifiers
| code_info | Lot: 183220013C Exp. 12/19/2018 |
|---|
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-0333-2019%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.