FDA-Drug2024-05-29Class III

Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

Dr. Reddy's Laboratories, Inc.
Hazard

Failed Impurities/Degradation Specifications

Sold states
US Nationwide.
Affected count
1,176 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0504-2024

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