Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Mahabubnagar, India | Makes it | Problems found, fixed voluntarilyAug 12, 2022 · 5 inspections, 1 with FDA action |
Recalls
- Jan 10, 2018 · Class II · Hetero Labs, Ltd. - Unit III
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Lots: Lot #: ARI17089, ARI17090, Exp. 5/2019
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, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA205064
- On the market since
- Apr 28, 2015
- Package NDCs
31722-820-0131722-820-0531722-820-3031722-820-3131722-820-32- Official label
- DailyMed (National Library of Medicine), updated Feb 2, 2024
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