Simvastatin Tablet, Film Coated
FDA Recall NDC 16729-005
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Simvastatin (NDC 16729-005). 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
205,631 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
Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; 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) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103877, P2103958, Exp. Date 5/31/2023, R2101393, R2101395, R2101394, Exp. Date 10/31/2023, P2202681, P2202653, Exp. Date 4/30/2025; b)R2000555, R2000587, R2000599, R2000604, Exp. Date 9/30/2023; P2100023, P2006857, Exp. Date 11/30/2023, P2101094, P2101096, P2101110, P2101111, P2101113, P2101145, P2101198, P2101223, P2101199, Exp. Date 1/31/2024, P2101877, P2101885, P2101886, P2101929, R2100402, R2100406, R2100403, Exp. Date 2/28/2024, P2101786, P2101787, P2101789, P2101790, Exp. Date 2/29/2024, R2100440, R2100439, Exp. Date 3/31/2024
Affected Packages Involved in this Recall
16729-005-10Product
16729-005-12Product
16729-005-15Product
16729-005-17Product
16729-006-10Product
16729-006-12Product
16729-006-15Product
16729-006-17Product
16729-007-10Product
16729-007-12Product
16729-007-15Product
16729-007-17Product
16729-156-10Product
16729-156-15Product
16729-156-17Product
16729-004-10Product
16729-004-12Product
16729-004-15Product
16729-004-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
256,648 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
Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 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) R2100818, Exp. Date 6/30/2023; R2100964, Exp. Date 6/30/2023; R2100824, Exp. Date 6/30/2023; R2100820, Exp. Date 6/30/2023; R2100822, Exp. Date 6/30/2023; R2101201, Exp. Date 9/30/2023; R2101198, Exp. Date 9/30/2023; R2101199, Exp. Date 9/30/2023; R2101200, Exp. Date 9/30/2023; R2101355, Exp. Date 10/31/2023; R2200035, Exp. Date 10/31/2023; R2200515, Exp. Date 4/30/2025; R2200514, Exp. Date 4/30/2025; R2200516, Exp. Date 4/30/2025; b) R2200310, Exp Date 9/30/2023; R2101354, Exp. Date 10/31/2023; R2200513, Exp. Date 4/30/2025; R2200768, Exp. Date 5/31/2025
Affected Packages Involved in this Recall
16729-005-10Product
16729-005-12Product
16729-005-15Product
16729-005-17Product
16729-006-10Product
16729-006-12Product
16729-006-15Product
16729-006-17Product
16729-007-10Product
16729-007-12Product
16729-007-15Product
16729-007-17Product
16729-156-10Product
16729-156-15Product
16729-156-17Product
16729-004-10Product
16729-004-12Product
16729-004-15Product
16729-004-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
1,394,208 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
Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; 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) P2102261, P2102284, P2102319, Exp. Date 3/31/2023, P2103536, Exp. Date 5/31/2023, P2104344, P2104342, P2104355, P2104356, P2104296, P2104380, Exp. Date 6/30/2023, R2200238, R2200239, Exp. Date 1/31/2024, R2200383, Exp. Date 2/28/2025; b) R2000554, R2000553, Exp. Date 9/30/2023; P2100562, P2100563,Exp. Date 12/31/2023; P2100692, P2100693, P2100722, P2100761, P2100762, P2101225, P2101200, P2101148, P2101149, P2101276, P2101345, Exp. Date 1/31/2024; P2101622, P2101664, P2101638, P2101785, P2101904, Exp. Date 2/29/2024; P2101951, P2101984, P2102367, P2102369, P2102368, P2102311, P2102316, P2102406, P2102455, Exp. Date 3/31/2024; P2102553, P2102554, P2102635, P2103233, P2103253, Exp. Date 4/30/2024; P2103360, P2103322, P2103414, P2103444, P2103415, P2103447, P2103573, P2103594, P2103615, P2103679, P2103648, P2103691, P2103646, P2103629, P2103704, P2103731, P2103763, P2103788, P2103789, P2103766, P2103876, P2103959, P2103833, Exp. Date 5/31/2024; P2103992; P2104045, P2104002, P2104046, P2104381, P2104407, P2104389, P2104644, P2104409, P2104649, P2104673, P2104684, P2104743, P2104696, P2104695, P2104745, P2105154, R2100826, R2100819, R2100829, P2104697, P2104746, P2105194, R2100837, R2100830, R2100836, P2105196, P2105220, P2105195, P2105222, R2100851, R2100856, Exp. Date 6/30/2024; P2105879, P2105920, P2105937, P2105973, P2105940, P2105986, P2105997, P2106009, P2106001, P2106010, P2106159, P2106182, P2106168, P2106202, P2106203, P2106217, P2106233, P2106214, P2106245, Exp. Date 8/31/2024; P2106333, P2106327, P2106342, P2106374, P2106405, P2106416, P2106429, P2106423, P2106412, Exp. Date 9/30/2024; R2200377, R2200542, R2200543, Exp. Date 2/28/2025; P2202795, P2202420, P2202445, Exp. Date 3/31/2025; R2200598, R2200590, R2200596, R2200591, P2202817, P2203290, P2202818, P2202819, Exp. Date 4/30/2025; P2203050, P2203006, P2203051, Exp. Date 5/31/2025
Affected Packages Involved in this Recall
16729-005-10Product
16729-005-12Product
16729-005-15Product
16729-005-17Product
16729-006-10Product
16729-006-12Product
16729-006-15Product
16729-006-17Product
16729-007-10Product
16729-007-12Product
16729-007-15Product
16729-007-17Product
16729-156-10Product
16729-156-15Product
16729-156-17Product
16729-004-10Product
16729-004-12Product
16729-004-15Product
16729-004-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
291,378 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
Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 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) P2106923, Exp. Date 9/30/2023; R2101544, Exp. Date 10/31/2023; R2200732, Exp. Date 5/31/2025; b) P2101634, Exp. Date 2/28/2023; P2102370, Exp. Date 3/31/2023; P2102321, Exp. Date 3/31/2023; P2102411, Exp. Date 3/31/2023; P2102454, Exp. Date 3/31/2023; P2103991, Exp. Date 5/31/2023; R2100954, Exp. Date 6/30/2023; R2100947, Exp. Date 6/30/2023; R2100951, Exp. Date 6/30/2023; P2106242, Exp. Date 8/31/2023; P2106928, Exp. Date 9/30/2023; P2107424, Exp. Date 9/30/2023; R2101542, Exp. Date 10/31/2023; R2101543, Exp. Date 10/31/2023; R2200026, Exp. Date 11/30/2023; R2200414, Exp. Date 2/29/2024; R2200416, Exp. Date 2/28/2025; R2200586, Exp. Date 4/30/2025; R2200679, Exp. Date 5/31/2025; R2200824, Exp. Date 5/31/2025
Affected Packages Involved in this Recall
16729-005-10Product
16729-005-12Product
16729-005-15Product
16729-005-17Product
16729-006-10Product
16729-006-12Product
16729-006-15Product
16729-006-17Product
16729-007-10Product
16729-007-12Product
16729-007-15Product
16729-007-17Product
16729-156-10Product
16729-156-15Product
16729-156-17Product
16729-004-10Product
16729-004-12Product
16729-004-15Product
16729-004-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
1,190,484 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
Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; 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) P2103713, P2103692, Exp. Date 5/31/2023, P2104950, P2104984, P2104969, P2104996, P2105274, P2105314, P2105316, Exp. Date 7/31/2023, R2101074, R2101077, R2101078, R2101079, R2101083, R2101084, R2101117, Exp. Date 8/31/2023, R2101330, R2101331, R2101335, R2101336, R2101334, R2101337, R2101339, Exp. Date 9/30/2023, R2101494, R2101495, R2101496, R2101497, Exp. Date 10/31/2023, R2200527, R2200531, Exp. Date 3/31/2024, R2200606, R2200625, Exp. Date 4/30/2024; b) P2101911, P2101913, R2100344, R2100351, R2100354, R2100346, R2100357, R2100358, R2100359, R2100361, R2100362, R2100385, R2100386, R2100388, R2100394, R2100397, R2100345, Exp. Date 2/28/2023; P2101930, P2101983, R2100435, R2100457, R2100433, R2100462, R2100466, R2100465, R2100469, R2100468, Exp. Date 3/31/2023; P2103223, P2103229, P2103234, Exp. Date 4/30/2023; P2103254, P2103258, P2103261, P2103323, P2103362, P2103364, P2103310, P2103671, P2103678, P2103545, P2103568, P2103599, P2103616, P2103627, P2103649, P2103813, P2103832, P2103834, P2103867, P2103868, P2103901, P2103912, Exp. Date 5/31/2023; P2105024, P2105027, P2105028, P2105049, P2105047, P2105052, P2105340, P2105341, P2105420, P2105432, P2105445, P2105455, P2105456, P2105467, P2105461, Exp. Date 7/31/2024; R2101118, R2101119, R2101127, R2101128, R2101134, R2101145, R2101133, R2101146, R2101149, R2101164, R2101169, R2101165, R2101187, R2101188, R2101192, R2101193, R2101168, R2101194, Exp. Date 8/31/2024; R2101516, R2101517, R2101515, R2101523, R2101525, R2101524, R2101530, R2101531, R2101532, R2101534, R2101533, R2101541, R2101547, R2101569, R2101567, R2101568, R2101571, R2101580, R2101582, R2101592, R2101583, R2101581, R2101593, P2107446, Exp. Date 10/31/2024; P2107791, P2107792, Exp. Date 11/30/2024; R2200271, R2200272, R2200275, Exp. Date 1/31/2025; R2200374, R2200379, R2200378, R2200391, Exp. Date 2/28/2025; R2200457, R2200458, R2200540, R2200470, R2200541, R2200459, R2200451, R2200471, Exp. Date 3/31/2025; R2200610, R2200611, R2200616, R2200615,R2200624, R2200628, R2200736, Exp. Date 4/30/2025, R2200688, R2200681, R2200687, Exp. Date 5/31/2025
Affected Packages Involved in this Recall
16729-005-10Product
16729-005-12Product
16729-005-15Product
16729-005-17Product
16729-006-10Product
16729-006-12Product
16729-006-15Product
16729-006-17Product
16729-007-10Product
16729-007-12Product
16729-007-15Product
16729-007-17Product
16729-156-10Product
16729-156-15Product
16729-156-17Product
16729-004-10Product
16729-004-12Product
16729-004-15Product
16729-004-17Product
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.
