D-0504-2024 Class III Ongoing
FDA drug recall D-0504-2024 was initiated by Dr. Reddy's Laboratories, Inc. on May 1, 2024 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is ongoing. Affected quantity: 1,176 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2024
- Initiation Date
- May 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,176 bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
US Nationwide.
Code Information
Lot H2200493; Exp 6/30/2025