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Ranbaxy Issues Voluntary Nationwide Recall of 41 lots of Atorvastatin Calcium Tablets 10 mg, 20 mg and 40 mg Due to Potential Presence of Foreign Substance
Date:11/28/2012

PRINCETON, N.J., Nov. 28, 2012 /PRNewswire/ -- On November 9, 2012, Ranbaxy Inc. initiated a voluntary recall of 41 affected lots of Atorvastatin Calcium Tablets (10 mg, 20 mg and 40 mg) which is a solid oral dosage form, to the retail level. The Company is taking this voluntary action as a precautionary measure due to the fact that we cannot exclude the possibility that the affected lots may contain very small glass particles resembling a fine grain of sand (less than 1 mm in size). This information is available in Ranbaxy's website at www.ranbaxyusa.com. The recall does not affect or relate to the 80 mg dosage strength of Atorvastatin Calcium Tablets.

The probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out.  Because of the size of the particles which may be present in the affected lots it is unlikely to cause a significant safety concern. However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out. As of this date, Ranbaxy has not received any reports of adverse events related to this recall.

The product is used to lower blood cholesterol and is packaged in plastic bottles, as 90 and 500 tablets per bottle. The affected lots of Atorvastatin Calcium Tablets and their respective NDC code, expiration date information are listed below. The product is a white colored tablet and can be identified by the imprint RX12 on 10 mg tablets, RX828 on 20 mg tablets and RX829 on 40 mg tablets.  The product was distributed in the USA to wholesalers and retailers.

Ranbaxy has notified its distributors and retailers by e-mail/ FedEx and has arranged for return of the affected lots.  Distributors/retailers have stopped further distribution of the affected lots and are in the process of returning any affected product to Ranbaxy.

Consumers with questions regarding this recall can contact Ranbaxy's Customer Coordinator (Inmar) at 1-866-266-7623, Monday to Friday, 8:00 AM to 5:00 PM CST.  Consumers should immediately contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Online:www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178
  • This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

    Following is the list of affected lots:ProductLot numberPack SizeNDC #Expiry DateATORVASTATIN Calcium Tablets 10mg x 90

    2436144

    90's Bottle

    63304-827-90

    31-Aug-14ATORVASTATIN Calcium Tablets 10mg x 90

    2436582

    90's Bottle

    63304-827-90

    31-Aug-14ATORVASTATIN Calcium Tablets 10mg x 90

    2441567

    90's Bottle

    63304-827-90

    31-Aug-14ATORVASTATIN Calcium Tablets 10mg x 90

    2441568

    90's Bottle

    63304-827-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2436731

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2437381

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2437940

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2437942

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2437945

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2437947

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2437952

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2437953

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2437960

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2440676

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2440677

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2440680

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 20mg x 90

    2440681

    90's Bottle

    63304-828-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 500

    2437956

    500's Bottle

    63304-829-05

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 500

    2437957

    500's Bottle

    63304-829-05

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 500

    2440675

    500's Bottle

    63304-829-05

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2434265

    90's Bottle

    63304-829-90

    31-Jul-14ATORVASTATIN Calcium Tablets 40mg x 90

    2434266

    90's Bottle

    63304-829-90

    31-Jul-14ATORVASTATIN Calcium Tablets 40mg x 90

    2434824

    90's Bottle

    63304-829-90

    31-Jul-14ATORVASTATIN Calcium Tablets 40mg x 90

    2434826

    90's Bottle

    63304-829-90

    31-Jul-14ATORVASTATIN Calcium Tablets 40mg x 90

    2434827

    90's Bottle

    63304-829-90

    31-Jul-14ATORVASTATIN Calcium Tablets 40mg x 90

    2434828

    90's Bottle

    63304-829-90

    31-Jul-14ATORVASTATIN Calcium Tablets 40mg x 90

    2434829

    90's Bottle

    63304-829-90

    31-Jul-14ATORVASTATIN Calcium Tablets 40mg x 90

    2434830

    90's Bottle

    63304-829-90

    31-Jul-14ATORVASTATIN Calcium Tablets 40mg x 90

    2434831

    90's Bottle

    63304-829-90

    31-Jul-14ATORVASTATIN Calcium Tablets 40mg x 90

    2436580

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2436725

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2436727

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2436729

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2437377

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2437380

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2437941

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2437943

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2437944

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2437949

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2437950

    90's Bottle

    63304-829-90

    31-Aug-14ATORVASTATIN Calcium Tablets 40mg x 90

    2437955

    90's Bottle

    63304-829-90

    31-Aug-14 

    Media Inquiries:

    Charles M. Caprariello
    Vice President, Corporate Communications
    Ranbaxy Inc.
    (609) 720-5615About Ranbaxy Inc.

    Ranbaxy Inc. is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company.


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    SOURCE Ranbaxy Inc.
    Copyright©2012 PR Newswire.
    All rights reserved

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