Status
Terminated
Drug Enforcement D-0411-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Report Date
March 8, 2023
Termination Date
April 22, 2024
Product Information
- 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
- Product quantity
- 1,190,484 bottles
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States including Puerto Rico and Canada
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0411-2023
- Event ID
- 91657
- Recall initiation date
- February 7, 2023
- Center classification date
- March 2, 2023
- Code info
- 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;
- More code info
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