Teva Recalls Copaxone Syringes Due to Foreign Particulate Matter
Teva Pharmaceuticals is recalling 6,803 cartons of Copaxone pre-filled syringes because a foreign particle was found in one unit.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or property damage (or structural defects) map to a score of 4. While no injuries are reported, the presence of particulate matter in an injectable drug is a significant safety hazard.
Plain-English summary
Teva Pharmaceuticals USA is recalling 6,803 cartons of Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringes. The recall was initiated after a consumer complaint reported the presence of a foreign particle in a pre-filled syringe.
The affected product is identified by Lot X06381 with an expiration date of 10/14. The product is distributed nationwide and is marketed by Teva Neuroscience, Inc., and distributed by Teva Pharmaceuticals USA, Inc.
Consumers who have this product should stop using it and contact their healthcare provider or Teva Pharmaceuticals for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- COPAXONE (GLATIRAMER ACETATE)
- Brand
- COPAXONE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Injectable
- Affected units
- 6,803
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot X06381
- Exp 10/14
UPCs (1)
- 368546317304
Distribution
Distributed nationwide across the United States.
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