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Ranbaxy Pharmaceuticals Inc. has initiated a recall of certain batches and strengths of Atorvastatin calcium tablets – the company’s generic version of Lipitor. The recall only affect products distributed in the United States.

The recall notice posted on Ranbaxy’s web site reads as follows:

Atorvastatin Recall

Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall only in the U.S. healthcare system for select batches and strengths of Atorvastatin calcium tablets. The recall is in connection with its 10mg 20mg and 40mg dosage strengths, packaged in 90’s and 500 count bottles, and only with respect to certain select lot numbers. The recall does not affect or relate to the 80mg strength or any other Ranbaxy Product in any other market.

The recall is being conducted in the U.S. at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the U.S. FDA. The recall is limited to the U.S. market only and affects specific lots numbers and strengths of this molecule manufactured by Ranbaxy only for sale in the U.S.

Atorvastatin calcium tablets or any other product containing this molecule distributed outside the US is not affected in any way by this recall. The activities taking place in the U.S. will not affect Ranbaxy’s ability to continue to supply product in any other markets.

Individuals who have been prescribed atorvastatin calcium in the 10mg, 20mg or 40mg dosage strengths should refer to the list of recalled products supplied by Ranbaxy, and should contact their pharmacist for additional instructions.

Three of Ranbaxy’s manufacturing facilities have been operating under a consent decree of permanent injunction, filed by the US Department of Justice in January 2012. The consent decree addressed “…outstanding current good manufacturing practice (CGMP) and data integrity issues at Ranbaxy’s Paonta Sahib, Batamandi and Dewas, India facilities as well as CGMP issues at Ranbaxy Inc.’s wholly owned subsidiary Ohm Laboratories facility located in Gloversville, N.Y.” When queried by eFoodAlert today about this recall, Sarah Clark-Lynn of FDA’s Office of Public Affairs responded with the following statement:

First, let me say that consumers in this country expect and deserve safe, effective, and high quality medications. The FDA is working with the company to address their quality issues.

Product from the affected lots of atorvastatin (see Ranbaxy’s website for the lot numbers) may have been dispensed to patients and may have already been consumed. Patients concerned about the product they have on hand should contact their pharmacist and consult with their physician.

The FDA is currently working with other manufacturers to address any potential shortage as a result of the ongoing recall. We will continue to monitor this situation.

The Ranbaxy facilities involved in manufacturing atorvastatin were not the same facilities whose conduct gave rise to the consent decree. Nonetheless, the consent decree provides the FDA with additional tools to address violations for other Ranbaxy facilities.

The evaluation of this quality issue is ongoing.

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