Simvastatin Tablet, Film Coated
FDA Recall NDC 65862-052
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 Simvastatin (NDC 65862-052). A significant event, classified as Class II, was initiated on Mar 18, 2020 by Aurobindo Pharma Limited. The reported reason for this action was: "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed"
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
Class II Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mar 18, 2020
Apr 22, 2020
26976 units
Recall Profile & Regulatory Data
Event ID
85183
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 25, 2024
Product Description
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
Batch or Lot Expiration Information
Lot# : 05319004A1, Exp. Date 03/2022
Affected Packages Involved in this Recall
65862-050-30Product
65862-050-45Product
65862-050-90Product
65862-050-01Product
65862-050-00Product
65862-050-99Product
65862-050-26Product
65862-051-30Product
65862-051-45Product
65862-051-90Product
65862-051-01Product
65862-051-00Product
65862-051-99Product
65862-051-26Product
65862-052-30Product
65862-052-45Product
65862-052-90Product
65862-052-01Product
65862-052-00Product
65862-052-99Product
65862-052-26Product
65862-053-30Product
65862-053-45Product
65862-053-90Product
65862-053-01Product
65862-053-00Product
65862-053-99Product
65862-053-22Product
65862-054-30Product
65862-054-45Product
65862-054-90Product
65862-054-00Product
65862-054-99Product
65862-054-39Product
July 2019 Class III Recall: Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Recall Number
Class III Terminated
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Jul 29, 2019
Sep 04, 2019
2,352/1000 count bottles
Recall Profile & Regulatory Data
Event ID
83436
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide by three major distributors who may have further distributed the product.
Termination Date
Oct 28, 2021
Product Description
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Batch or Lot Expiration Information
Lot# 05318054B, exp 3/2021
Affected Packages Involved in this Recall
65862-050-30Product
65862-050-45Product
65862-050-90Product
65862-050-01Product
65862-050-00Product
65862-050-99Product
65862-050-26Product
65862-051-30Product
65862-051-45Product
65862-051-90Product
65862-051-01Product
65862-051-00Product
65862-051-99Product
65862-051-26Product
65862-052-30Product
65862-052-45Product
65862-052-90Product
65862-052-01Product
65862-052-00Product
65862-052-99Product
65862-052-26Product
65862-053-30Product
65862-053-45Product
65862-053-90Product
65862-053-01Product
65862-053-00Product
65862-053-99Product
65862-053-22Product
65862-054-30Product
65862-054-45Product
65862-054-90Product
65862-054-00Product
65862-054-99Product
65862-054-39Product
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.
