Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufa...
FDA Recall #D-109-2013 — Class I — September 26, 2012
Product Description
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
Recalling Firm
New England Compounding Center — Framingham, MA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
9062 vials
Distribution
Nationwide
Code Information
All lot codes
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated