Drug product
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
D-1064-2018
Product summary
- Event
- Event 80118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 400-ml ON-Q Pump
- Official record key
drug-enforcement:D-1064-2018
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 59088:42 Use By: 05/24/2018; 59159:42 Use By: 05/30/2018
Distribution pattern: Texas
Derived failure modes
-
Sterility assurance
Lack of sterility