New Delhi, July 2016: Dr. Reddy’s Laboratories is recalling almost 10,000 bottles of its Sirolimus tablets in the USA after impurities were detected in the medication.

Sirolimus is used to prevent chances of organ rejection after kidney transplants.

The latest Enforcement Report of United States Food and Drug Administration (USFDA) says the pharmaceutical major is recalling 9,330 bottles of Sirolimus tablets (1 mg) on account of “failed impurities/degradation: out of specification result for impurity secorapamycin,”

The nation-wide recall is a voluntary procedure, falling under Class III, which means that the “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

The tablets were manufactured by Dr Reddy’s Laboratories at its Visakhapatnam plant.


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