Dr. Reddy's Laboratories, Inc. has recalled 1,176 bottles of Sirolimus (1mg, 100-count), a prescription medication used to prevent organ rejection after a kidney transplant. The recall was initiated because the product failed to meet approved specifications for impurities or degradation, meaning the drug may not maintain its quality or safety standards through its expiration date. This recall affects only 100-count bottles with NDC 55111-653-01 and lot H2200493.
The presence of impurities or degradation products exceeding safety limits may impact the effectiveness of the medication or lead to unintended side effects, though the current risk is classified as low.
You have 2 options:
Recall number D-0504-2024
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.