FDA recall D-1051-2018

Guardian Pharmacy Services · Class II · drug

Product

Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. 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-1051-2018