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.
Reported: February 14, 2018 Initiated: November 30, 2017 #D-0323-2018
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.
Details
- Recalling Firm
- Intrathecal Compounding Specialist, LLC
- Units Affected
- Unknown
- Distribution
- Nationwide
- Location
- Scott, LA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Intrathecal Compounding Specialist, LLC. Units affected: Unknown.
Why was this product recalled? ▼
Lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2018. Severity: Moderate. Recall number: D-0323-2018.
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