Enforcement Report - Week of August 15, 2012
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Product Detail
| Product Description | Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 |
|---|---|
| Recall Number | D-1442-2012 |
| Classification | Class II |
| Code Info | Lot number X05011, Exp 08/13 |
| Product Distributed Qty | 6,647 cartons |
| Reason For Recall | Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint. |
Event Detail
| Event Id | 62241 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Teva Pharmaceuticals USA, Inc. |
| City | Sellersville |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-18 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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