Why it was recalled
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
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.
Lot numbers, UPCs & expiration codes
Lot X06381, Exp 10/14
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-001-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 24, 2013
- FDA report date
- Nov 27, 2013
- Quantity
- 6,803 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-001-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 66672
- Address
- 425 Privet Rd
- Code information
- Lot X06381, Exp 10/14
- Postal code
- 19044-1220
- Report date
- Nov 27, 2013
- Product type
- Drugs
- Recall number
- D-001-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 6,803 cartons
- Termination date
- Aug 27, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 24, 2013
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2013