Recall: D-0504-2024

Class III - Minor Violations

Class IIIClassification

2024-05-01Initiated

OngoingStatus

Dr. Reddy's Laboratories, Inc.Firm

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

Reason

Failed Impurities/Degradation Specifications

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.