FDA recall D-0032-2017

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 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-0032-2017