FDA recall D-0320-2018

Product

All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.

Reason for recall

Lack of sterility assurance.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-11-30

Report date

2018-02-14

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Scott, LA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2018