FDA recall D-1146-2017

Bella Pharmaceuticals, Inc. · Class II · drug

Product

PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.

Reason for recall

Lack of Assurance of Sterility.

Distribution

Nationwide within USA

Key facts

Status
Terminated
Initiation date
2017-08-15
Report date
2017-09-20
Termination date
2018-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1146-2017