FDA recall D-0038-2017

Pharmedium Services, LLC · Class II · drug

Product

fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.

Reason for recall

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-07-17
Report date
2016-10-19
Termination date
2017-06-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0038-2017