Drug Enforcement D-055-2013

GMP deficiencies

Status

Terminated

Classification

Class II

Report Date

November 21, 2012

Termination Date

July 25, 2016

Product Information

Product description
All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
Product quantity
Reason for recall
GMP deficiencies
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
Ameridose LLC
Address
201 Flanders Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-055-2013
Event ID
63585
Recall initiation date
October 31, 2012
Center classification date
November 14, 2012
Code info
All lot codes within expiry
More code info