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Immunosuppressant Recalled


July 14, 2016

The US Food and Drug Administration (FDA) announced the recall of 9,330 bottles of sirolimus tablets, 1 mg.

What’s the reason for the recall? The FDA noted that the products were out of specification for an impurity.

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The products were manufactured by Dr. Reddy’s Laboratories in India.

A number of lots were impacted. See below:

Lot

Expiration

H400044

July 2016

H400045

July 2016

H400048

August 2016

H400055

October 2016

H400070

November 2016

H400071

November 2016

H400073

November 2016

H400074

November 2016

 

In April, Dr. Reddy’s launched a recall of 3,342 vials of zoledronic acid injection because the company could not assure the sterility of the product.

Click here to read the report.

 

--Stephanie Vaccaro

 

Reference:

US Food and Drug Administration. FDA Enforcement Report – Week of July 13, 2016. www.fda.gov. Accessed July 14, 2016.

 

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