Drug product
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61
D-0959-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 850 syringes
- Official record key
drug-enforcement:D-0959-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: Lot #: 5/7/18 0301 2-80761S, BUD 6/21/2018; 5/9/18 0510 2-80761S, BUD 6/23/2018; 5/21/18 1807 80761S, BUD 7/15/2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility