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Atorvastatin Calcium Tablets by Ranbaxy Inc.: Recall - Presence of Foreign Substance

Posted Nov 28 2012 5:30pm

[Posted 11/28/2012]

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: 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). 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.

BACKGROUND: 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 can be found in the Firm Press Release. The recall does not affect or relate to the 80 mg dosage strength of Atorvastatin Calcium Tablets.

RECOMMENDATION:  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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • 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.
     

[11/29/2012 - Questions and Answers - FDA]

[11/29/2012 - FDA Statement - FDA]

[11/28/2012 - Firm Press Release - Ranbaxy Inc.]

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