FDA recall D-115-2013

New England Compounding Center · Class II · drug

Product

Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2012-09-26
Report date
2013-01-09
Termination date
2016-10-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Framingham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-115-2013