Drug product
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
D-0068-2018
Product summary
- Event
- Event 78320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 487 syringes
- Official record key
drug-enforcement:D-0068-2018
Official wording
Reason: Lack Of Assurance Of Sterility.
Code information: Lot: 20171004@4 BUD: 01/09/2018
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Sterility assurance
Lack Of Assurance Of Sterility