FDAClass IIAugust 15, 2012

Copaxone recall

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

Why was Copaxone recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number X05011, Exp 08/13

Product
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Recalling firm
Teva Pharmaceuticals USA, Inc.
Quantity
6,647 cartons
Distribution
Nationwide
Recall date
August 15, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls