Drug product
0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
D-0535-2016
Product summary
- Event
- Event 72594
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 bags
- Official record key
drug-enforcement:D-0535-2016
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