Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
Recall Number: D-1063-2016
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class III
Status: Terminated
Report Date: 20160713
Initiation Date: 20160603
Termination Date: 20170407
Reason for Recall
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Product Description
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01