Drug product
Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50
D-0178-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 517 syringes
- Official record key
drug-enforcement:D-0178-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 03262018:11 Discard by: 4/25/2018; 04102018:38 Discard by: 5/10/2018; 05312018:63 Discard by: 6/30/2018; 05032018:97 Discard by: 6/2/2018; 06082018:24 Discard by: 7/8/2018; 05212018:80 Discard by: 6/20/2018; 07102018:60 Discard by: 8/9/2018; 06202018:44 Discard by: 7/19/2018; 07232018:08 Discard by: 8/22/2018; 07022018:62 Discard by: 8/1/2018; 08292018:95 Discard by: 9/28/2018; 08202018:61 Discard by: 9/19/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility