Drug product
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
D-0504-2024
Product summary
- Event
- Event 94535
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1,176 bottles
- Official record key
drug-enforcement:D-0504-2024
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot H2200493; Exp 6/30/2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications