Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012
  • Print
  • Share
  • E-mail
-
Back to Previous Page

Product Detail

Product Description 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.
Recall Number D-072-2013
Classification Class II
Code Info 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.
Product Distributed Qty 157,026 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
-
-