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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

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

PR Newswire

PRINCETON, N.J., Nov. 28, 2012

PRINCETON, N.J., Nov. 28, 2012 /PRNewswire/ --On November 9, 2012, Ranbaxy
Inc. initiated a voluntaryrecallof 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.

  oOnline:www.fda.gov/medwatch/report.htm
  oRegular 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.
  oFax: 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:

Product                       Lot number Pack Size    NDC #        Expiry Date
ATORVASTATIN Calcium Tablets  2436144    90's Bottle  63304-827-90 31-Aug-14
10mg x 90
ATORVASTATIN Calcium Tablets  2436582    90's Bottle  63304-827-90 31-Aug-14
10mg x 90
ATORVASTATIN Calcium Tablets  2441567    90's Bottle  63304-827-90 31-Aug-14
10mg x 90
ATORVASTATIN Calcium Tablets  2441568    90's Bottle  63304-827-90 31-Aug-14
10mg x 90
ATORVASTATIN Calcium Tablets  2436731    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2437381    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2437940    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2437942    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2437945    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2437947    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2437952    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2437953    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2437960    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2440676    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2440677    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2440680    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2440681    90's Bottle  63304-828-90 31-Aug-14
20mg x 90
ATORVASTATIN Calcium Tablets  2437956    500's Bottle 63304-829-05 31-Aug-14
40mg x 500
ATORVASTATIN Calcium Tablets  2437957    500's Bottle 63304-829-05 31-Aug-14
40mg x 500
ATORVASTATIN Calcium Tablets  2440675    500's Bottle 63304-829-05 31-Aug-14
40mg x 500
ATORVASTATIN Calcium Tablets  2434265    90's Bottle  63304-829-90 31-Jul-14
40mg x 90
ATORVASTATIN Calcium Tablets  2434266    90's Bottle  63304-829-90 31-Jul-14
40mg x 90
ATORVASTATIN Calcium Tablets  2434824    90's Bottle  63304-829-90 31-Jul-14
40mg x 90
ATORVASTATIN Calcium Tablets  2434826    90's Bottle  63304-829-90 31-Jul-14
40mg x 90
ATORVASTATIN Calcium Tablets  2434827    90's Bottle  63304-829-90 31-Jul-14
40mg x 90
ATORVASTATIN Calcium Tablets  2434828    90's Bottle  63304-829-90 31-Jul-14
40mg x 90
ATORVASTATIN Calcium Tablets  2434829    90's Bottle  63304-829-90 31-Jul-14
40mg x 90
ATORVASTATIN Calcium Tablets  2434830    90's Bottle  63304-829-90 31-Jul-14
40mg x 90
ATORVASTATIN Calcium Tablets  2434831    90's Bottle  63304-829-90 31-Jul-14
40mg x 90
ATORVASTATIN Calcium Tablets  2436580    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2436725    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2436727    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2436729    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2437377    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2437380    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2437941    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2437943    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2437944    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2437949    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2437950    90's Bottle  63304-829-90 31-Aug-14
40mg x 90
ATORVASTATIN Calcium Tablets  2437955    90's Bottle  63304-829-90 31-Aug-14
40mg x 90



Media Inquiries:

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

About Ranbaxy Inc.

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

SOURCE Ranbaxy Inc.

Website: http://www.ranbaxyusa.com