NDC 70934-662
Aripiprazole 5 mg tablet
On the label: Denton Pharma, Inc. DBA Northwind Pharmaceuticals.. It's repackaged: Denton Pharma, Inc. DBA Northwind Pharmaceuticals. rebottles it from Accord Healthcare Inc.'s NDC 16729-279.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals, Location not on file · repackages it
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2005474, Exp 9/30/2023; P2100001, Exp 12/31/2023; P2100789, P2100790, Exp 1/31/2024; P2101319, Exp 2/28/2024; P2102147, P2102148, Exp 3/31/2024; P2104084, Exp 6/30/2024; P2105410, P2107233, P2105411, Exp 7/31/2024; P2106671, P2106673, P2106675, Exp 9/30/2024; P2200428, P2200429, P2200… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2004259, P2004260, P2004261, Exp. Date 7/31/2023; P2006799, P2101391, Exp. Date 11/30/2023; P2100826, Exp. Date 1/31/2024; P2101320, Exp. Date 2/28/2024; P2102510, P2102409, P2102407, Exp. Date 3/31/2024; P2102410, Exp. Date 3/31/2024; P2105251, P2105252, P2105253, Exp. Date 7/31/2024;… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a)P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944, Exp. Date 8/31/2023; P2107593, P2106907, P2106906, P2106908, P2106909, Exp. Date 10/31/2024; b)P2102144, Exp. Date 3/31/2023; P2106903 Exp. Date 10/31/2023; P2204437, Exp. Date 7/31/2025; - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2004997, P2004998, P2004999, Exp. Date 8/31/2023; P2101206, Exp. Date 1/31/2024 , P2102486, Exp. Date 4/30/2024; P2106247, P2105375, Exp. Date 7/31/2024; P2107239, P2107240, Exp. Date 10/31/2024; b) P2204222 Exp. Date 7/31/2025, P2105374 Exp. 7/31/2024, P2203449 Exp. 5/31/2025 - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2100787, P2100788, Exp. Date 1/31/2024; P2104736, Exp. Date 6/30/2024; P2105492, Exp. Date 8/31/2024; P2107172, P2107175, Exp. Date 10/31/2024; P2203043, Exp. Date 5/31/2025; b) P2104086 Exp. Date 6/30/2024, P2205370 Exp. 8/31/2025; - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2005477, Exp. Date 9/30/2023; P2100002, Exp. Date 12/31/2023; P2101359 Exp. Date 2/28/2024; P2105409, Exp. Date 7/31/2024; P2107447, Exp. Date 10/31/2024; P2203388 Exp. Date 5/31/2025; b) P2101859 Exp. Date 2/28/2023; P2107056, Exp. Date 10/31/2023; P2203066, Exp. Date 5/31/2024; P22…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Aripiprazole: every company that makes it
- Form
- tablet
- Strength
- 5 mg
- Approval
- ANDA ANDA206251
- On the market since
- Apr 7, 2020
- Package NDCs
70934-662-30- Official label
- DailyMed (National Library of Medicine), updated Aug 12, 2021
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