Lovastatin Tablet
FDA Recall NDC 68180-469
Latest: Class III · Status: Terminated · Initiated Feb 13, 2019 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lovastatin (NDC 68180-469). A significant event, classified as Class III, was initiated on Feb 13, 2019 by Lupin Pharmaceuticals, Inc.. 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 13, 2019
Feb 27, 2019
44,640 bottles
Recall Profile & Regulatory Data
Event ID
82126
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Termination Date
Oct 06, 2020
Product Description
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
Batch or Lot Expiration Information
Lot# : a) G702755, Exp March 2020; b) G702756, Exp March 2020
Affected Packages Involved in this Recall
68180-467-09Lovastatin
68180-467-07Lovastatin
68180-467-01Lovastatin
68180-467-03Lovastatin
68180-467-05Lovastatin
68180-468-07Lovastatin
68180-468-01Lovastatin
68180-468-03Lovastatin
68180-468-05Lovastatin
68180-468-09Lovastatin
68180-469-07Lovastatin
68180-469-01Lovastatin
68180-469-03Lovastatin
68180-469-05Lovastatin
68180-469-09Lovastatin
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.
