FDA recall D-124-2013

Product

Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 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-124-2013