Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 |
|---|---|
| Recall Number | D-060-2013 |
| Classification | Class II |
| Code Info | Lot #: 2407258, Exp 05/14 |
| Product Distributed Qty | 32,208 bottles |
| Reason For Recall | Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. |
Event Detail
| Event Id | 63623 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Ranbaxy Inc. |
| City | Princeton |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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