FDA recall D-879-2013

Product

Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-03-25

Report date

2013-08-21

Termination date

2013-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-879-2013