Drug product
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22
D-0061-2018
Product summary
- Event
- Event 78320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 bags
- Official record key
drug-enforcement:D-0061-2018
Official wording
Reason: Lack Of Assurance Of Sterility.
Code information: Lot: 20170816@65 BUD: 10/30/2017
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Sterility assurance
Lack Of Assurance Of Sterility