D-0323-2018 Class II Terminated
FDA drug recall D-0323-2018 was initiated by Intrathecal Compounding Specialist, LLC on November 30, 2017 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated May 1, 2019). Affected quantity: Unknown.
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).