D-1064-2018 Class II Terminated
FDA drug recall D-1064-2018 was initiated by Guardian Pharmacy Services on May 17, 2018 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated November 25, 2020). Affected quantity: 20 400-ml ON-Q Pump.
Recall Details
- Product Type
- Drugs
- Report Date
- August 15, 2018
- Initiation Date
- May 17, 2018
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 400-ml ON-Q Pump
Product Description
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
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Texas
Code Information
Lots: 59088:42 Use By: 05/24/2018; 59159:42 Use By: 05/30/2018