Teva Recalls Copaxone Syringes Due to Visible Silicone Oil Presence
Teva Pharmaceuticals is recalling 6,692 boxes of Copaxone (glatiramer acetate) injection due to visible medical grade silicone oil in the syringes.
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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with significant patient complaints regarding product integrity.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 6,692 boxes of Copaxone (glatiramer acetate injection), 20 mg/1 mL. The product is packaged in 30 single-use pre-filled syringes and 33 alcohol preps per box. The specific lot affected is P53847, with an expiration date of 01/14. The product was distributed nationwide.
The recall was initiated due to an elevated number of patient complaints regarding the visible presence of medical grade silicone oil. This substance is essential to the functionality of the syringe and plunger stopper system. The FDA has classified this recall as Class II.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The recall is limited to the specific lot number and expiration date listed above.
The recalled product
- Product
- COPAXONE (GLATIRAMER ACETATE)
- Brand
- COPAXONE
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 6,692
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 P53847
- Exp 01/14
Distribution
Distributed nationwide across the United States.
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