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

FDA recall notice · announced February 14, 2018 · Intrathecal Compounding Specialist

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

All sterile drug preparations remaining within expiry prepared from Hydromorphone 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.

Notes

Distribution: Nationwide
Lot/code information: All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017).
Quantity: Unknown
Status: Terminated
Products in this recall event:
- All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Sp (D-0322-2018)
- 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 Specia (D-0320-2018)
- 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 Spe (D-0323-2018)
- All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Speciali (D-0321-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.