Drug Enforcement D-108-2013

Non-Sterility

Status

Terminated

Classification

Class I

Report Date

January 9, 2013

Termination Date

October 7, 2016

Product Information

Product description
Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Product quantity
23,897 vials
Reason for recall
Non-Sterility
Recall initiation reason
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide

Location & Firm

Recalling firm
New England Compounding Center
Address
697 Waverly St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-108-2013
Event ID
63305
Recall initiation date
September 26, 2012
Center classification date
December 31, 2012
Code info
All Lot codes
More code info