Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manu...

FDA Recall #D-110-2013 — Class I — September 26, 2012

Recall #D-110-2013 Date: September 26, 2012 Classification: Class I Status: Terminated

Product Description

Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 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

5130 vials

Distribution

Nationwide

Code Information

All lot codes

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated