Enforcement Report - Week of December 5, 2012
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Product Detail
| Product Description | Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90 |
|---|---|
| Recall Number | D-070-2013 |
| Classification | Class II |
| Code Info | Lot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014. |
| Product Distributed Qty | 120,201 Bottles |
| Reason For Recall | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. |
Event Detail
| Event Id | 63759 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Ranbaxy Inc. |
| City | Princeton |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-09 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and PR |
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