Lovastatin Tablet
FDA Recall NDC 68001-314
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lovastatin (NDC 68001-314). A significant event, classified as Class III, was initiated on Feb 19, 2019 by Bluepoint Laboratories. The reported reason for this action was: "CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results."
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 III Terminated
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Feb 19, 2019
Aug 14, 2019
14,360 bottles
Recall Profile & Regulatory Data
Event ID
83471
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA and Puerto Rico
Termination Date
Sep 09, 2020
Product Description
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
Batch or Lot Expiration Information
Lot# : a) G702705 and b) G702706, Exp. 3/31/2020
Affected Packages Involved in this Recall
68001-314-00Product
68001-314-08Product
68001-315-00Product
68001-315-08Product
68001-316-00Product
68001-316-08Product
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.
