FDA Drug recall D-0032-2017
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Conte…
- FDA Drug
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Conte… by Pharmedium Services, citing stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0032-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-17 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmedium Services |
| Distribution | US |
Product
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Identifiers
| code_info | Lot Numbers: 151000045M, 15127040M, 15133026M, 15141029M, 151930078M, 15132103M, Exp between 07/15/15-10/12/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0032-2017%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.