Intas Pharmaceuticals Limited
Ahmedabad, India · makes it and tests it
No problems found Last FDA inspection Jul 12, 2024. 10 inspections on record.
NDC 10544-907
simvastatin 80 mg tablet, film coated
On the label: Blenheim Pharmacal, Inc..
It's a repackaged product: Blenheim Pharmacal, Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-007.
Where the pills inside were made
Intas Pharmaceuticals Limited
Ahmedabad, India · makes it and tests it
Serious problems, FDA action Last FDA inspection Dec 2, 2022. 7 inspections on record, 1 with serious problems.
Repackaging site
- Blenheim Pharmacal, Inc., · repackages it
Recalls
- Feb 7, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: 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… - Feb 7, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: 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; … - Feb 7, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: 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; P21005… - Feb 7, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: 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, R210… - Feb 7, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: 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. D…
Product details
- Generic drug
- Simvastatin: see every company that makes it
- Form
- tablet, film coated
- Strength
- 80 mg
- Approval
- ANDA ANDA078155
- On the market since
- Mar 26, 2015
- Package NDCs
10544-907-30- Official label
- DailyMed (National Library of Medicine), updated Nov 25, 2015
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