Atorvastatin Calcium Tablet
FDA Recall NDC 55111-124
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Atorvastatin Calcium (NDC 55111-124). A significant event, classified as Class III, was initiated on Mar 16, 2022 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of Specification results for related substance."
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
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Mar 16, 2022
Apr 06, 2022
28,068 bottles
Recall Profile & Regulatory Data
Event ID
89833
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Nov 13, 2023
Product Description
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90
Batch or Lot Expiration Information
Lot# Lot: T000707, T000756, T000758, T000759, Exp 03/2022; T2100600, T2101075, Exp. 1/2023; T2102802, Exp. 07/2023
Affected Packages Involved in this Recall
55111-124-30Product
55111-124-60Product
55111-124-90Product
55111-124-05Product
Class II Terminated
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
May 30, 2018
Jun 27, 2018
6,397 bottles
Recall Profile & Regulatory Data
Event ID
80208
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 14, 2020
Product Description
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
Batch or Lot Expiration Information
Lot# : T800064, Exp 12/2019
Affected Packages Involved in this Recall
55111-124-30Product
55111-124-60Product
55111-124-90Product
55111-124-05Product
3551111249Product
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.
