Drug product
Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
D-0545-2016
Product summary
- Event
- Event 72594
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 syringes
- Official record key
drug-enforcement:D-0545-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within expiry.
Distribution pattern: Texas
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility