Home / Recalls / Intrathecal Compounding Specialist, LLC / D-0323-2018

D-0323-2018 Class II Terminated

Recalled by Intrathecal Compounding Specialist, LLC — Scott, LA

Recall Details

Product Type
Drugs
Report Date
February 14, 2018
Initiation Date
November 30, 2017
Termination Date
May 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Unknown

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.

Distribution Pattern

Nationwide

Code Information

All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017).

Other recalls by Intrathecal Compounding Specialist, LLC

  • D-0320-2018 Class II — All sterile drug preparations remaining within expiry prepared from Fentanyl Cit (November 30, 2017)
  • D-0321-2018 Class II — All sterile drug preparations remaining within expiry prepared from Hydromorphon (November 30, 2017)
  • D-0322-2018 Class II — All sterile drug preparations remaining within expiry prepared from Morphine Sul (November 30, 2017)