All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solu...
FDA Recall #D-0323-2018 — Class II — November 30, 2017
Product Description
All sterile drug preparations remaining within expiry prepared from Sufentanil 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.
Recalling Firm
Intrathecal Compounding Specialist, LLC — Scott, LA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
Unknown
Distribution
Nationwide
Code Information
All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017).
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated