FDA recall D-0003-2015

New England Home Therapies, Inc · Class II · drug

Product

All sterile drugs compounded between 2/21/14 and 2/24/14.

Reason for recall

Lack of Assurance of Sterility: All compounded products.

Distribution

US: New England

Key facts

Status
Terminated
Initiation date
2014-02-26
Report date
2014-10-08
Termination date
2016-08-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Southborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2015