FDA Statement on the Ranbaxy Atorvastatin Recall

[11/29/2012] On Nov. 9, 2012, Ranbaxy Pharmaceuticals informed its customers of a voluntary recall of certain lots of the company’s 10mg, 20mg, and 40mg dosage strengths of atorvastatin tablets. The lots of atorvastatin, packaged in bottles of 90 and 500 tablets, are being recalled due to possible contamination with very small glass particles similar to the size of a grain of sand (less than 1 mm in size).

Due to this quality issue, Ranbaxy has decided to stop manufacturing atorvastatin until it has thoroughly investigated the cause of the glass particulates and remedied the problem. Based on the information from Ranbaxy and from the FDA’s initial assessment, the possibility of adverse events related to the recalled product appear to be low, and if any adverse events are experienced, they would be temporary.

At this time, we have not received any reports of patient harm due to glass particulates that may be in the recalled product.

Consumers who are concerned that they may have received a recalled product should consult with their pharmacist where they bought the product to confirm whether they received a recalled product, should stop taking the product if it was recalled, and should consult with their pharmacist or physician about how to obtain an alternative product.

Americans expect and deserve safe, effective, and high quality medications. The FDA continues to evaluate information associated with this recall and will notify the public as new information becomes available. The agency will continue to oversee the recall process, and work with the Ranbaxy to resolve these pharmaceutical quality issues.

Atorvastatin is a widely used cholesterol lowering medication that is available from several manufacturers. While there is no anticipated drug shortage for any of the affected lots or strengths, the FDA is proactively monitoring the situation for the possibility of a shortage. The FDA is working with other manufacturers of atorvastatin to ensure adequate market supply in order to avoid shortages of atorvastatin as a result of this ongoing recall.

If patients experience any adverse events, they should contact their health care provider. Health care professionals and consumers can also report adverse events to MedWatch, FDA’s adverse event reporting program:

    Complete and submit the report online: www.fda.gov/MedWatch/report.htm, or
    Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.


Recalled Products

 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
 

 
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Related Information

    Questions and Answers on the Ranbaxy Atorvastatin Recall

Posted: November 2012


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