FDA recall D-1442-2012

Teva Pharmaceuticals USA, Inc. · Class II · drug

Product

Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2012-05-18
Report date
2012-08-15
Termination date
2013-04-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1442-2012