NDC 61919-245
Lansoprazole 15 mg capsule, delayed release
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-398.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it and relabels it
Recalls
- Mar 23, 2022 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; during long term stability testing.
Lots: Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023. - Mar 23, 2022 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; during long term stability testing.
Lots: Lot# C2102911, Exp. 12/2023
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
- capsule, delayed release
- Strength
- 15 mg
- Approval
- ANDA ANDA091269
- On the market since
- Jan 1, 2014
- Package NDCs
61919-245-3061919-245-60- Official label
- DailyMed (National Library of Medicine), updated Oct 10, 2019
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