FDA recall D-109-2013

New England Compounding Center · Class I · drug

Product

Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

Reason for recall

Non-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-109-2013