FDA recall D-1066-2018

Product

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.

Distribution

Texas

Key facts

Status

Terminated

Initiation date

2018-05-17

Report date

2018-08-15

Termination date

2020-11-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1066-2018