Simvastatin Tablet
FDA Recall NDC 42571-080
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 42571-080). A significant event, classified as Class III, was initiated on Dec 04, 2014 by Micro Labs Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Product failed a known impurity specification."
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
December 2014 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Dec 04, 2014
Mar 18, 2015
13464 bottles
Recall Profile & Regulatory Data
Event ID
69928
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Micro Labs Usa, Inc S
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Apr 25, 2018
Product Description
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Batch or Lot Expiration Information
Lot# : STEG004, Exp 2/2015
Lot# : STEG006 Exp 3/2015
Affected Packages Involved in this Recall
42571-010-30Product
42571-010-60Product
42571-010-90Product
42571-010-05Product
42571-010-10Product
42571-005-30Product
42571-005-60Product
42571-005-90Product
42571-005-05Product
42571-005-10Product
42571-020-30Product
42571-020-60Product
42571-020-90Product
42571-020-05Product
42571-020-10Product
42571-040-30Product
42571-040-60Product
42571-040-90Product
42571-040-05Product
42571-040-10Product
42571-080-30Product
42571-080-60Product
42571-080-90Product
42571-080-05Product
42571-080-10Product
August 2014 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Aug 19, 2014
Nov 19, 2014
1,008 bottles
Recall Profile & Regulatory Data
Event ID
69268
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Micro Labs Usa, Inc S
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NY
Termination Date
Apr 19, 2016
Product Description
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
Batch or Lot Expiration Information
Lot# : STBG005, Exp 2/2015
Affected Packages Involved in this Recall
42571-010-30Product
42571-010-60Product
42571-010-90Product
42571-010-05Product
42571-010-10Product
42571-005-30Product
42571-005-60Product
42571-005-90Product
42571-005-05Product
42571-005-10Product
42571-020-30Product
42571-020-60Product
42571-020-90Product
42571-020-05Product
42571-020-10Product
42571-040-30Product
42571-040-60Product
42571-040-90Product
42571-040-05Product
42571-040-10Product
42571-080-30Product
42571-080-60Product
42571-080-90Product
42571-080-05Product
42571-080-10Product
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.
