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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012
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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014. Class II Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. 120,201 Bottles D-070-2013
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 Lot #s: 2436731, 2437381, 2437940, 2437942, 2437945, 2437947, 2437952, 2437953, 2437960, 2440676, 2440677, 2440680, 2440681, Exp 08/31/2014. Class II Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. 203,198 Bottles D-071-2013
Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05. a) 40 mg 90 count, Lot #s: 2434265, 2434266, 2434824, 2434826, 2434827, 2434828, 2434829, 2434830, 2434831, Exp 07/31/2014; 2436580, 2436725, 2436727, 2436729, 2437377, 2437380, 2437941, 2437943, 2437944, 2437949, 2437950, 2437955, Exp 08/31/2014. b) 40 mg 500 count, Lot #s: 2437956, 2437957, 2440675, Exp 08/31/2014. Class II Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. 157,026 Bottles D-072-2013
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