FDA-Drug2016-07-13Class III

Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01

Dr. Reddy's Laboratories, Inc.
Hazard

Failed impurities/degradation: out of specification result for impurity secorapamycin.

Sold states
Nationwide
Affected count
9,330 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1063-2016

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