Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Umedica Laboratories Private Limited | Vapi, India | Makes it and tests it | Problems found, fixed voluntarilyMar 29, 2024 · 4 inspections |
Recalls
- Sep 24, 2024 · Class II · Nivagen Pharmaceuticals Inc
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Lots: Lot #: U24T0408A, Exp: 03/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atorvastatin: every company that makes it
- Form
- tablet, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA213853
- On the market since
- Aug 26, 2020
- Package NDCs
75834-257-0175834-257-2575834-257-5075834-257-90- Official label
- DailyMed (National Library of Medicine), updated Oct 23, 2026
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