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U.S. Department of Health and Human Services

Drugs

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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 NumberPack 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