NDC 33342-111
Montelukast sodium 5 mg tablet, chewable
On the label: Macleods Pharmaceuticals Limited.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | District Solan, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 20, 2023 · 6 inspections, 2 with FDA action |
Recalls
- Jan 20, 2020 · Class III · Macleods Pharma Usa Inc
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Lots: Lot #: BMD8901B, Exp. Date 02/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, chewable, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA203582
- On the market since
- Mar 13, 2015
- Package NDCs
33342-111-0733342-111-1033342-111-1233342-111-1533342-111-3933342-111-44- Official label
- DailyMed (National Library of Medicine), updated Jul 6, 2023
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