Dr. Reddy’s Issues Voluntary Recall of Select Lots of ParicalcitolBy
Dr. Reddy Laboratories has issued a voluntary Class III recall for select lots of paricalcitol capsules due to failed tablet/capsule specifications. The product was recalled due to reports of breakage and leakage of paricalcitol capsules. The recall was noted in the February 24, 2016 US Food and Drug Administration Weekly Enforcement Report.
A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The recall applies to 4383 bottles of paricalcitol capsules, 2 mcg, 30 capsules per bottle, prescription only and 11,123 bottles of paricalcitol capsules, 4 mcg, 30 capsules per bottle,prescription only and manufactured by: Dr. Reddy’s Laboratories Limited, Bachupally, India.
The recall applies to the United States and was initiated on November 4, 2015.
The drug is used for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.