Sirolimus Tablet
FDA Recall NDC 55111-653
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sirolimus (NDC 55111-653). A significant event, classified as Class III, was initiated on May 01, 2024 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradation Specifications
May 01, 2024
May 29, 2024
1,176 bottles
Recall Profile & Regulatory Data
Event ID
94535
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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
Batch or Lot Expiration Information
Lot# Lot H2200493; Exp 6/30/2025
Affected Packages Involved in this Recall
55111-653-30Product
55111-653-01Product
55111-654-30Product
55111-654-01Product
Class III Terminated
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Jun 03, 2016
Jul 13, 2016
9,330 bottles
Recall Profile & Regulatory Data
Event ID
74325
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 07, 2017
Product Description
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
Batch or Lot Expiration Information
Lot# H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
Affected Packages Involved in this Recall
55111-653-30Product
55111-653-01Product
55111-654-30Product
55111-654-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
