Drug 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.
D-0321-2018
Product summary
- Event
- Event 78669
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0321-2018
Official wording
Reason: Lack of sterility assurance.
Code information: All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of sterility