Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla Limited | Pune, India | Makes it and makes the active ingredient | Problems found, fixed voluntarilyMay 8, 2024 · 7 inspections |
| Cipla Limited | Bengaluru, India | Makes the active ingredient | Problems found, fixed voluntarilyMay 30, 2025 · 4 inspections |
Recalls
- Dec 17, 2020 · Class II · Cipla
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Lots: Lot #: KA00413, KA00414, KA00461, Exp 11/2021 - Dec 17, 2020 · Class II · Cipla
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Lots: Lot #: KA00415, KA00416, Exp 11/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Esomeprazole: every company that makes it
- Form
- for suspension, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA211751
- On the market since
- Mar 24, 2020
- Package NDCs
69097-529-34- Official label
- DailyMed (National Library of Medicine), updated May 13, 2024
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