NDC 68382-771
Lansoprazole 15 mg tablet, orally disintegrating
On the label: Zydus Pharmaceuticals (USA) Inc..
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
- Dec 3, 2020 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications
Lots: M915744 OCT 2021 M904770 FEB 2021 - Dec 3, 2020 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications
Lots: M900412 December 2020 M904772 February 2021 M915745 October 2021 - Oct 27, 2020 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specification
Lots: Lot # M005681, EXP 3/2022 - Oct 27, 2020 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specification
Lots: Lot # M005682, EXP 3/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lansoprazole: every company that makes it
- Form
- tablet, orally disintegrating, oral
- Strength
- 15 mg
- Approval
- ANDA ANDA200816
- On the market since
- Nov 30, 2018
- Package NDCs
68382-771-3068382-771-77- Official label
- DailyMed (National Library of Medicine), updated Aug 22, 2022
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