Sirolimus Tablets 1mg Tablets 100-count bottle recall: Impurity Out of Spec
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
Why was Sirolimus Tablets 1mg Tablets 100-count bottle recalled?
Failed Impurities/Degradation Specifications
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot H2200493; Exp 6/30/2025
- 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
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 1,176 bottles
- Distribution
- US Nationwide.
- Recall date
- May 29, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)