2014

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

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.

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 10mg x 90

2436144

90's Bottle

63304-827-90

31-Aug-14

ATORVASTATIN Calcium Tablets 10mg x 90

2436582

90's Bottle

63304-827-90

31-Aug-14

ATORVASTATIN Calcium Tablets 10mg x 90

2441567

90's Bottle

63304-827-90

31-Aug-14

ATORVASTATIN Calcium Tablets 10mg x 90

2441568

90's Bottle

63304-827-90

31-Aug-14






ATORVASTATIN Calcium Tablets 20mg x 90

2436731

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2437381

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2437940

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2437942

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2437945

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2437947

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2437952

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2437953

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2437960

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2440676

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2440677

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2440680

90's Bottle

63304-828-90

31-Aug-14

ATORVASTATIN Calcium Tablets 20mg x 90

2440681

90's Bottle

63304-828-90

31-Aug-14






ATORVASTATIN Calcium Tablets 40mg x 500

2437956

500's Bottle

63304-829-05

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 500

2437957

500's Bottle

63304-829-05

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 500

2440675

500's Bottle

63304-829-05

31-Aug-14






ATORVASTATIN Calcium Tablets 40mg x 90

2434265

90's Bottle

63304-829-90

31-Jul-14

ATORVASTATIN Calcium Tablets 40mg x 90

2434266

90's Bottle

63304-829-90

31-Jul-14

ATORVASTATIN Calcium Tablets 40mg x 90

2434824

90's Bottle

63304-829-90

31-Jul-14

ATORVASTATIN Calcium Tablets 40mg x 90

2434826

90's Bottle

63304-829-90

31-Jul-14

ATORVASTATIN Calcium Tablets 40mg x 90

2434827

90's Bottle

63304-829-90

31-Jul-14

ATORVASTATIN Calcium Tablets 40mg x 90

2434828

90's Bottle

63304-829-90

31-Jul-14

ATORVASTATIN Calcium Tablets 40mg x 90

2434829

90's Bottle

63304-829-90

31-Jul-14

ATORVASTATIN Calcium Tablets 40mg x 90

2434830

90's Bottle

63304-829-90

31-Jul-14

ATORVASTATIN Calcium Tablets 40mg x 90

2434831

90's Bottle

63304-829-90

31-Jul-14

ATORVASTATIN Calcium Tablets 40mg x 90

2436580

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2436725

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2436727

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2436729

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2437377

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2437380

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2437941

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2437943

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2437944

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2437949

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN Calcium Tablets 40mg x 90

2437950

90's Bottle

63304-829-90

31-Aug-14

ATORVASTATIN 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) 720-5615  

About Ranbaxy Inc.

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

SOURCE Ranbaxy Inc.



RELATED LINKS
http://www.ranbaxyusa.com

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