Atorvastatin Calcium Tablet
FDA Recall NDC 75834-257
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 Atorvastatin Calcium (NDC 75834-257). A significant event, classified as Class II, was initiated on Sep 24, 2024 by Nivagen Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg."
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
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Sep 24, 2024
Oct 09, 2024
2328 bottles
Recall Profile & Regulatory Data
Event ID
95418
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Nivagen Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Termination Date
Jul 01, 2026
Product Description
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
Batch or Lot Expiration Information
Lot# : U24T0408A, Exp: 03/31/2026
Affected Packages Involved in this Recall
75834-256-90Product
75834-256-01Product
75834-256-05Product
75834-256-50Product
75834-255-90Product
75834-255-01Product
75834-255-05Product
75834-255-50Product
75834-257-90Product
75834-257-50Product
75834-257-25Product
75834-257-01Product
75834-258-90Product
75834-258-50Product
75834-258-02Product
75834-258-01Product
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.
