Drugs

FDA Statement on the Ranbaxy Atorvastatin Recall

En Español

Update: 11/30/2012

FDA is notifying the public that after reviewing additional information related to the Ranbaxy atorvastatin recall, FDA has determined that the possibility of adverse health problems related to the recalled atorvastatin is extremely low.

 What patients should know

  • Patients who have the recalled medicine can continue taking it unless directed otherwise by their physician or health care provider.

  • To date, FDA hasn’t received any reports of injury.

  • The possibility of adverse health problems related to the recalled atorvastatin is extremely low.

  • If patients experience any adverse events, they should contact their health care provider, and report to FDA’s MedWatch program.

  • Ranbaxy decided to stop making atorvastatin until the company has thoroughly investigated the cause of the contamination and remedied the problem.

  • The recall does not include atorvastatin 80mg strength or any other Ranbaxy product.

  • FDA will continue to oversee the recall process and work with Ranbaxy to resolve quality issues.

  • The FDA does not anticipate a drug shortage. FDA is working with other atorvastatin manufacturers to avoid a drug shortage and is closely monitoring the situation.
     

[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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