Ezetimibe And Simvastatin Tablet
FDA Recall NDC 43598-745
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Ezetimibe And Simvastatin (NDC 43598-745). A significant event, classified as Class II, was initiated on Oct 05, 2021 by Dr.reddys Laboratories Inc. The reported reason for this action was: "Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
October 2021 Class II Recall: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Recall Number
Class II Terminated
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Oct 05, 2021
Nov 10, 2021
a) 30,839 bottles, b) 3,830 bottles
Recall Profile & Regulatory Data
Event ID
88798
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Feb 16, 2023
Product Description
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Batch or Lot Expiration Information
Lot# a) L100298 and L100304, exp 01/2023 b) L100235, exp 01/2023
Affected Packages Involved in this Recall
43598-742-30Product
43598-742-90Product
43598-742-10Product
43598-744-30Product
43598-744-90Product
43598-744-10Product
43598-743-30Product
43598-743-90Product
43598-743-05Product
43598-745-30Product
43598-745-90Product
43598-745-05Product
October 2021 Class II Recall: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Recall Number
Class II Terminated
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Oct 05, 2021
Nov 10, 2021
a) 776 bottles, b) 84 bottles
Recall Profile & Regulatory Data
Event ID
88798
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Feb 16, 2023
Product Description
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles.
Batch or Lot Expiration Information
Lot# a) L100256, exp 01/2023; b) L100257, exp 01/2023
Affected Packages Involved in this Recall
43598-742-30Product
43598-742-90Product
43598-742-10Product
43598-744-30Product
43598-744-90Product
43598-744-10Product
43598-743-30Product
43598-743-90Product
43598-743-05Product
43598-745-30Product
43598-745-90Product
43598-745-05Product
October 2021 Class II Recall: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Recall Number
Class II Terminated
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Oct 05, 2021
Nov 10, 2021
a) 11,590 bottles b) 3,585 bottles
Recall Profile & Regulatory Data
Event ID
88798
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Feb 16, 2023
Product Description
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Batch or Lot Expiration Information
Lot# a) L100158, exp 12/2022 b) L100159, exp 12/2022
Affected Packages Involved in this Recall
43598-742-30Product
43598-742-90Product
43598-742-10Product
43598-744-30Product
43598-744-90Product
43598-744-10Product
43598-743-30Product
43598-743-90Product
43598-743-05Product
43598-745-30Product
43598-745-90Product
43598-745-05Product
October 2021 Class II Recall: Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Recall Number
Class II Terminated
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Oct 05, 2021
Nov 10, 2021
696 bottles
Recall Profile & Regulatory Data
Event ID
88798
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Feb 16, 2023
Product Description
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05
Batch or Lot Expiration Information
Lot# L100208, exp 01/2023
Affected Packages Involved in this Recall
43598-742-30Product
43598-742-90Product
43598-742-10Product
43598-744-30Product
43598-744-90Product
43598-744-10Product
43598-743-30Product
43598-743-90Product
43598-743-05Product
43598-745-30Product
43598-745-90Product
43598-745-05Product
October 2021 Class II Recall: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Recall Number
Class II Terminated
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Oct 05, 2021
Nov 10, 2021
a) 3,444 bottles b) 469 bottles c) 142 bottles
Recall Profile & Regulatory Data
Event ID
88798
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Feb 16, 2023
Product Description
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Batch or Lot Expiration Information
Lot# a) L100160, exp 01/2023 b) L100249, exp 01/2023 c) L100250, exp 01/2023
Affected Packages Involved in this Recall
43598-742-30Product
43598-742-90Product
43598-742-10Product
43598-744-30Product
43598-744-90Product
43598-744-10Product
43598-743-30Product
43598-743-90Product
43598-743-05Product
43598-745-30Product
43598-745-90Product
43598-745-05Product
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.
