Drug product
fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64
D-0063-2018
Product summary
- Event
- Event 78320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 bags inside rigid translucent plastic cases (CADD)
- Official record key
drug-enforcement:D-0063-2018
Official wording
Reason: Lack Of Assurance Of Sterility.
Code information: Lot: 20170815@26 BUD: 11/13/2017
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Sterility assurance
Lack Of Assurance Of Sterility