Copaxone Injection, Solution
FDA Recall NDC 68546-317
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Copaxone (NDC 68546-317). A significant event, classified as Class II, was initiated on Oct 24, 2013 by Teva Neuroscience, Inc.. The reported reason for this action was: "Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Oct 24, 2013
Nov 27, 2013
6,803 cartons
Recall Profile & Regulatory Data
Event ID
66672
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 27, 2014
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot X06381, Exp 10/14
Affected Packages Involved in this Recall
68546-317-00Product
68546-317-30Product
68546-325-06Product
68546-325-12Product
Class II Terminated
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Dec 05, 2012
Apr 24, 2013
6,692 boxes
Recall Profile & Regulatory Data
Event ID
63819
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 05, 2013
Product Description
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30
Batch or Lot Expiration Information
Lot# Lot P53847, Exp 01/14
Affected Packages Involved in this Recall
68546-317-00Product
68546-317-30Product
68546-325-06Product
68546-325-12Product
Class II Terminated
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
May 18, 2012
Aug 15, 2012
6,647 cartons
Recall Profile & Regulatory Data
Event ID
62241
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 11, 2013
Product Description
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Batch or Lot Expiration Information
Lot# Lot number X05011, Exp 08/13
Affected Packages Involved in this Recall
68546-317-00Product
68546-317-30Product
68546-325-06Product
68546-325-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
