Atorvastatin Calcium Tablet
FDA Recall NDC 75834-258
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 75834-258). 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 recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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
Ongoing
Recalling Firm
Nivagen Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
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.
