Enforcement Report - Week of January 23, 2013
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Product Detail
| Product Description | CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88 |
|---|---|
| Recall Number | D-128-2013 |
| Classification | Class III |
| Code Info | Lot number 6A007046V, exp 07/12 |
| Product Distributed Qty | 13,232 bottles |
| Reason For Recall | Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life |
Event Detail
| Event Id | 61725 |
|---|---|
| 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 | 2012-04-24 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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