Ezetimibe And Simvastatin Tablet
FDA Recall NDC 51407-192
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 Ezetimibe And Simvastatin (NDC 51407-192). A significant event, classified as Class II, was initiated on Oct 14, 2021 by Golden State Medical Supply, Inc.. The reported reason for this action was: "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"
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 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 14, 2021
Nov 17, 2021
a) 101 b) 145 bottles
Recall Profile & Regulatory Data
Event ID
88866
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to two distributors located in AZ and MO
Termination Date
Nov 10, 2022
Product Description
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
Batch or Lot Expiration Information
Lot# a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023
Affected Packages Involved in this Recall
51407-190-30Product
51407-190-90Product
51407-190-10Product
51407-191-30Product
51407-191-90Product
51407-191-10Product
51407-192-30Product
51407-192-90Product
51407-192-05Product
51407-192-10Product
51407-193-30Product
51407-193-90Product
51407-193-05Product
October 2021 Class II Recall: Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Recall Number
Class II Terminated
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Oct 14, 2021
Nov 17, 2021
49
Recall Profile & Regulatory Data
Event ID
88866
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to two distributors located in AZ and MO
Termination Date
Nov 10, 2022
Product Description
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05
Batch or Lot Expiration Information
Lot# GS040048, Exp: 1/2023
Affected Packages Involved in this Recall
51407-190-30Product
51407-190-90Product
51407-190-10Product
51407-191-30Product
51407-191-90Product
51407-191-10Product
51407-192-30Product
51407-192-90Product
51407-192-05Product
51407-192-10Product
51407-193-30Product
51407-193-90Product
51407-193-05Product
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.
