Where it's 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 |
Recalls
- Oct 13, 2023 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Lots: Lot # C2305569, Exp. date 03/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, chewable, oral
- Strength
- 4 mg
- Approval
- ANDA ANDA201581
- On the market since
- Aug 6, 2012
- Package NDCs
55111-593-0555111-593-3055111-593-7855111-593-7955111-593-90- Official label
- DailyMed (National Library of Medicine), updated Oct 30, 2022
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