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Class II: temporary or reversible health riskTerminated

Teva Pharmaceuticals Copaxone Recall

Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Ne…

Teva Pharmaceuticals USA, Inc. · Sellersville, PA

Risk level
Class II
Reported by FDA
Aug 15, 2012
Recall ID
D-1442-2012
Check your lot numberHow we source this data

Summary

Teva Pharmaceuticals recalled Copaxone starting May 18, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1442-2012 on Aug 15, 2012. Reason: Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot number X05011, Exp 08/13

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1442-2012
Classification
Class II
Status
Terminated
Recall initiated
May 18, 2012
FDA report date
Aug 15, 2012
Quantity
6,647 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Teva Pharmaceuticals USA, Inc.

Original FDA data

Every field from FDA enforcement report D-1442-2012, exactly as published.

Show all FDA fields
City
Sellersville
State
PA
Status
Terminated
Country
United States
Event ID
62241
Address
650 Cathill Rd
Code information
Lot number X05011, Exp 08/13
Postal code
18960-1512
Report date
Aug 15, 2012
Product type
Drugs
Recall number
D-1442-2012
Classification
Class II
Recalling firm
Teva Pharmaceuticals USA, Inc.
Product quantity
6,647 cartons
Termination date
Apr 11, 2013
Reason for recall
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Distribution pattern
Nationwide
Recall initiation date
May 18, 2012
Initial firm notification
Letter
Center classification date
Aug 3, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1442-2012, published Aug 15, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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