FDA Drug recall D-0040-2017
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium,…
- FDA Drug
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium,… 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-0040-2017 |
| 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, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Identifiers
| code_info | Lot Numbers: 15103037M, 15117042M, 15126027M, 15127049M, 15131003M, 15119043M, 15138050M, 15141033M, 15142056M, 1514604…Lot Numbers: 15103037M, 15117042M, 15126027M, 15127049M, 15131003M, 15119043M, 15138050M, 15141033M, 15142056M, 15146040M, 15149039M, 151890299M, 151900220M, 151930019M, 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-0040-2017%22
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