FDA recall D-1068-2018

Product

Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV 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-1068-2018