FDA recall D-001-2014

Product

Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4.

Reason for recall

Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-10-24

Report date

2013-11-27

Termination date

2014-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-001-2014