Drug product
Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Texas --- NDC 69699-1203-50
D-0169-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 264 vials
- Official record key
drug-enforcement:D-0169-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 03152018:12 Discard by: 6/13/2018; 04182018:08 Discard by: 7/17/2018; 04302018:94 Discard by: 7/29/2018; 03292018:44 Discard by: 6/26/2018; 05212018:95 Discard by: 8/19/2018; 06142018:46 Discard by: 9/12/2018; 05312018:37 Discard by: 8/29/2018; 06282018:80 Discard by: 9/26/2018; 07312018:12 Discard by: 10/29/2018; 07102018:53 Discard by: 10/8/2018; 08222018:18 Discard by: 11/20/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility