Atorvastatin Calcium Tablet, Film Coated
FDA Recall NDC 16729-044
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Atorvastatin Calcium (NDC 16729-044). A significant event, classified as Class II, was initiated on Feb 07, 2023 by Accord Healthcare Inc.. The reported reason for this action was: "CGMP Deviations: recalling drug products following an FDA inspection."
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
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
256,106 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA.
Batch or Lot Expiration Information
Batch# Batches: a)R2100455, Exp. Date 3/31/2023; R2200274, Exp. Date 1/31/2024; R2200700, Exp. Date 5/31/2024; b) R2101342, R2101343, R2101476, Exp. Date 9/30/2023; R2101364, R2101365, R2101366, R2101367, Exp. Date 10/31/2023; R2101612, R2101613, R2101614, Exp. Date 11/30/2023; R2200222, R2200221, R2200223, Exp. Date 1/31/2024; R2200795, R2200713, R2200701, R2200711, R2200712, R2200756, R2200757, R2200754, R2200755, Exp. Date 5/31/2024; R2200945, R2200943, Exp. Date 6/30/2024
Affected Packages Involved in this Recall
16729-045-10Product
16729-045-15Product
16729-045-01Product
16729-045-16Product
16729-045-17Product
16729-044-10Product
16729-044-15Product
16729-044-01Product
16729-044-16Product
16729-044-17Product
16729-046-10Product
16729-046-15Product
16729-046-01Product
16729-046-16Product
16729-046-17Product
16729-047-10Product
16729-047-15Product
16729-047-01Product
16729-047-16Product
16729-047-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
147,736 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Batch or Lot Expiration Information
Batch# Batches: a)R2100552, R2100553, Exp. Date 4/30/2023; R2200253, Exp. Date 2/29/2024; R2200627, Exp. Date 4/30/2024; R2201113, Exp. Date 6/30/2024; R2201184, Exp. Date 8/31/2024; R2201366, Exp. Date 9/30/2024; b) R2200280, Exp. Date 2/29/2024; R2200385, R2200386, R2200491, R2200490, R2200494, R2200496, R2200495, Exp. Date 3/31/2024; R2200510, R2200520, R2200521, R2200517, R2200511, R2200632, R2200631, R2200637, R2200635, R2200648, R2200638, R2200639, R2200647, Exp. Date 4/30/2024; R2200727, Exp. Date 5/31/2024
Affected Packages Involved in this Recall
16729-045-10Product
16729-045-15Product
16729-045-01Product
16729-045-16Product
16729-045-17Product
16729-044-10Product
16729-044-15Product
16729-044-01Product
16729-044-16Product
16729-044-17Product
16729-046-10Product
16729-046-15Product
16729-046-01Product
16729-046-16Product
16729-046-17Product
16729-047-10Product
16729-047-15Product
16729-047-01Product
16729-047-16Product
16729-047-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
72,376 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Batch or Lot Expiration Information
Batch# Batches: a)R2100283, R2100288, R2100289, Exp. Date 2/28/2023; R2200235, Exp. Date 1/31/2024; R2201037, R2200952, Exp. Date 6/30/2024; b) R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2100347, R2100350, R2100356, R2100355, Exp. Date 2/28/2023; R2100461, R2100463, R2100464, Exp. Date 3/31/2023; R2101214, R2101215, R2101216, Exp. Date 9/30/2023; R2101572, R2101573, R2101577, R2101578, R2101585, R2101579, R2101584, R2101587, R2101597, Exp. Date 11/30/2023; R2200801, Exp. Date 6/30/2024
Affected Packages Involved in this Recall
16729-045-10Product
16729-045-15Product
16729-045-01Product
16729-045-16Product
16729-045-17Product
16729-044-10Product
16729-044-15Product
16729-044-01Product
16729-044-16Product
16729-044-17Product
16729-046-10Product
16729-046-15Product
16729-046-01Product
16729-046-16Product
16729-046-17Product
16729-047-10Product
16729-047-15Product
16729-047-01Product
16729-047-16Product
16729-047-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
241,585 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Batch or Lot Expiration Information
Batch# Batches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/2023; R2200228, R2200480, Exp. Date 1/31/2024; R2200266, R2200267, R2200265, R2200268, Exp. Date 2/29/2024; R2200370, Exp. Date 3/31/2024; R2201038, Exp. Date 6/30/2024
Affected Packages Involved in this Recall
16729-045-10Product
16729-045-15Product
16729-045-01Product
16729-045-16Product
16729-045-17Product
16729-044-10Product
16729-044-15Product
16729-044-01Product
16729-044-16Product
16729-044-17Product
16729-046-10Product
16729-046-15Product
16729-046-01Product
16729-046-16Product
16729-046-17Product
16729-047-10Product
16729-047-15Product
16729-047-01Product
16729-047-16Product
16729-047-17Product
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.
