FDA Drug recall D-0035-2017
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMED…
- FDA Drug
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMED… 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-0035-2017 |
| 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, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Identifiers
| code_info | Lot Numbers: 15118074M, 15120007M, 15124007M, 15127060M, 15132006M, 15132039M, 15138059M, 15139012M, 15139051M, 1514000…Lot Numbers: 15118074M, 15120007M, 15124007M, 15127060M, 15132006M, 15132039M, 15138059M, 15139012M, 15139051M, 15140003M, 15141067M, 15146006M, 15148075M, 151730112M, 151730155M, 151740205M, 151880329M, 151930020M, 151930026M, 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-0035-2017%22
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