Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Reported: August 15, 2018 Initiated: May 17, 2018 #D-1066-2018
Product Description
Ropivacaine HCl 2 mg/mL 750 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.
Details
- Recalling Firm
- Guardian Pharmacy Services
- Units Affected
- 3 750-ml ON-Q Pump
- Distribution
- Texas
- Location
- Dallas, TX
Frequently Asked Questions
What product was recalled? ▼
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247. Recalled by Guardian Pharmacy Services. Units affected: 3 750-ml ON-Q Pump.
Why was this product recalled? ▼
Lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 15, 2018. Severity: Moderate. Recall number: D-1066-2018.
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