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 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: Lot: M706674, M706676, M707685 EXP Jun-19; M711219, M711220, M711221, M711222, M711269, EXP Sep-19; M801027, EXP Dec-19; M801028, M801029, M801030, EXP Jan-20; M802206, EXP Feb-20, M805195, M805196, M805197, EXP Mar-20; M805199, M805202, M805944, M805945, M805948, M805951, M805953, M805956, M805957… - May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: Lot EXP Date: M708570 Jun-19, M711270 Sep-19, M802207 Feb-20, M812460 Aug-20
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
- Jun 27, 2010
- Package NDCs
68382-209-0668382-209-10- Official label
- DailyMed (National Library of Medicine), updated Jan 3, 2025
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