Atorvastatin Calcium Tablet, Film Coated
FDA Recall NDC 63304-830
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Atorvastatin Calcium (NDC 63304-830). A significant event, classified as Class II, was initiated on Mar 09, 2020 by Sun Pharmaceutical Industries Inc.. The reported reason for this action was: "Presence of foreign substance: Foreign matter has been identified as latex glove in one lot 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 substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Mar 09, 2020
Mar 25, 2020
1416 bottles
Recall Profile & Regulatory Data
Event ID
85184
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Feb 09, 2021
Product Description
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
Batch or Lot Expiration Information
Lot# : AA33617, Exp 03/2021
Affected Packages Involved in this Recall
63304-827-90Product
63304-827-05Product
63304-828-90Product
63304-828-05Product
63304-829-90Product
63304-829-05Product
63304-830-90Product
63304-830-05Product
Class II Terminated
Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Jan 16, 2014
Mar 05, 2014
64,626 bottles
Recall Profile & Regulatory Data
Event ID
67485
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ranbaxy Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 14, 2015
Product Description
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90
Batch or Lot Expiration Information
Lot# 2407255, 2407256 Exp. 05/14
Affected Packages Involved in this Recall
63304-827-90Product
63304-827-05Product
63304-828-90Product
63304-828-05Product
63304-829-90Product
63304-829-05Product
63304-830-90Product
63304-830-05Product
Class II Terminated
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Nov 09, 2012
Dec 05, 2012
120,201 Bottles
Recall Profile & Regulatory Data
Event ID
63759
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ranbaxy Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Termination Date
Apr 28, 2014
Product Description
Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90
Batch or Lot Expiration Information
Lot# s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014.
Affected Packages Involved in this Recall
63304-827-90Product
63304-827-05Product
63304-828-90Product
63304-828-05Product
63304-829-90Product
63304-829-05Product
63304-830-90Product
63304-830-05Product
Class II Terminated
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Nov 09, 2012
Dec 05, 2012
203,198 Bottles
Recall Profile & Regulatory Data
Event ID
63759
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ranbaxy Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Termination Date
Apr 28, 2014
Product Description
Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90
Batch or Lot Expiration Information
Lot# s: 2436731, 2437381, 2437940, 2437942, 2437945, 2437947, 2437952, 2437953, 2437960, 2440676, 2440677, 2440680, 2440681, Exp 08/31/2014.
Affected Packages Involved in this Recall
63304-827-90Product
63304-827-05Product
63304-828-90Product
63304-828-05Product
63304-829-90Product
63304-829-05Product
63304-830-90Product
63304-830-05Product
Class II Terminated
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Nov 09, 2012
Dec 05, 2012
157,026 Bottles
Recall Profile & Regulatory Data
Event ID
63759
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ranbaxy Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Termination Date
Apr 28, 2014
Product Description
Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.
Batch or Lot Expiration Information
Lot# a) 40 mg 90 count
Lot# s: 2434265, 2434266, 2434824, 2434826, 2434827, 2434828, 2434829, 2434830, 2434831, Exp 07/31/2014; 2436580, 2436725, 2436727, 2436729, 2437377, 2437380, 2437941, 2437943, 2437944, 2437949, 2437950, 2437955, Exp 08/31/2014. b) 40 mg 500 count
Lot# s: 2437956, 2437957, 2440675, Exp 08/31/2014.
Affected Packages Involved in this Recall
63304-827-90Product
63304-827-05Product
63304-828-90Product
63304-828-05Product
63304-829-90Product
63304-829-05Product
63304-830-90Product
63304-830-05Product
Class II Terminated
Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Aug 21, 2012
Nov 28, 2012
32,208 bottles
Recall Profile & Regulatory Data
Event ID
63623
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ranbaxy Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 06, 2014
Product Description
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90
Batch or Lot Expiration Information
Lot# : 2407258, Exp 05/14
Affected Packages Involved in this Recall
63304-827-90Product
63304-827-05Product
63304-828-90Product
63304-828-05Product
63304-829-90Product
63304-829-05Product
63304-830-90Product
63304-830-05Product
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.
