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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Detail

Product Description Atorvastatin Calcium Tablets, 20 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 #: 63304-828-90
Recall Number D-071-2013
Classification Class II
Code Info Lot #s: 2436731, 2437381, 2437940, 2437942, 2437945, 2437947, 2437952, 2437953, 2437960, 2440676, 2440677, 2440680, 2440681, Exp 08/31/2014.
Product Distributed Qty 203,198 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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