Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Recalls
- May 9, 2019 · Class II · American Health Packaging
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Lots: Count, Lot, Expiry: [30-count bottle] Lots M711214, M711215, M711216, M711217, exp 8/31/2019; Lots M802198, M802199, exp 1/31/2020; Lots M805203, M805204, M805207, exp 3/31/2019; Lots M812455, exp 6/30/2020; Lot M815766, exp 9/30/2020; Lots M818633, M818634, exp 10/31/2020; Lots M819858, M819…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Anastrozole: every company that makes it
- Form
- tablet, coated, oral
- Strength
- 1 mg
- Approval
- ANDA ANDA078921
- On the market since
- Jan 1, 2014
- Package NDCs
68001-155-0468001-155-08- Official label
- DailyMed (National Library of Medicine), updated Feb 10, 2025
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