Drug product
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
D-0065-2018
Product summary
- Event
- Event 78320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 450 bags
- Official record key
drug-enforcement:D-0065-2018
Official wording
Reason: Lack Of Assurance Of Sterility.
Code information: Lot: 20170912@13 BUD: 10/22/2017
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Sterility assurance
Lack Of Assurance Of Sterility