Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories...
FDA Recall #D-0504-2024 — Class III — May 1, 2024
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
Recalling Firm
Dr. Reddy's Laboratories, Inc. — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1,176 bottles
Distribution
US Nationwide.
Code Information
Lot H2200493; Exp 6/30/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.