FDA recall D-1073-2018
Guardian Pharmacy Services · Class II · drug
Product
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. 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-1073-2018