FDA recall D-1774-2019
Infusion Options, Inc. · Class II · drug
Product
ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Reason for recall
Lack of Assurance of Sterility
Distribution
NY only
Key facts
- Status
- Terminated
- Initiation date
- 2019-06-12
- Report date
- 2019-08-21
- Termination date
- 2025-03-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brooklyn, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1774-2019