Drug Enforcement D-052-2013

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

November 21, 2012

Termination Date

October 7, 2016

Product Information

Product description
All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
Product quantity
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide Japan

Location & Firm

Recalling firm
New England Compounding Center
Address
697 Waverly St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-052-2013
Event ID
63511
Recall initiation date
October 6, 2012
Center classification date
November 14, 2012
Code info
All lot codes
More code info