Drug Enforcement D-1442-2012

Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.

Status

Terminated

Classification

Class II

Report Date

August 15, 2012

Termination Date

April 11, 2013

Product Information

Product description
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Product quantity
6,647 cartons
Reason for recall
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc.
Address
650 Cathill Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1442-2012
Event ID
62241
Recall initiation date
May 18, 2012
Center classification date
August 3, 2012
Code info
Lot number X05011, Exp 08/13
More code info
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