Atorvastatin Calcium Tablet, Film Coated
FDA Recall NDC 60505-2579
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 60505-2579). A significant event, classified as Class III, was initiated on Oct 22, 2019 by Apotex Corp.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 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 III Terminated
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Oct 22, 2019
Nov 06, 2019
1968 bottles
Recall Profile & Regulatory Data
Event ID
84107
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Apotex Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
IL, MS, NJ, OH, TX
Termination Date
Feb 19, 2026
Product Description
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
Batch or Lot Expiration Information
Lot# Lot: RC5439 Exp. 03/2022
Affected Packages Involved in this Recall
60505-2578-3Product
60505-2578-9Product
60505-2578-5Product
60505-2578-8Product
60505-2578-7Product
60505-2578-0Product
60505-2579-3Product
60505-2579-9Product
60505-2579-5Product
60505-2579-8Product
60505-2579-7Product
60505-2579-0Product
60505-2580-3Product
60505-2580-9Product
60505-2580-5Product
60505-2580-8Product
60505-2580-7Product
60505-2580-0Product
60505-2671-3Product
60505-2671-9Product
60505-2671-5Product
60505-2671-8Product
60505-2671-7Product
60505-2671-0Product
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.
