FDA recall D-0647-2017
Fresenius Kabi USA, LLC · Class III · drug
Product
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
Reason for recall
Subpotent Drug
Distribution
Nationwide within the US
Key facts
- Status
- Terminated
- Initiation date
- 2017-03-16
- Report date
- 2017-04-12
- Termination date
- 2018-08-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Lake Zurich, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0647-2017