FDA recall D-1403-2019

Synthetopes Inc · Class II · drug

Product

Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.

Reason for recall

Lack of Processing Controls.

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2019-05-28
Report date
2019-06-19
Termination date
2020-10-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Conway, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1403-2019