NDC 33342-107
Risedronate Sodium 5 mg tablet, film coated
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
- Mar 10, 2022 · Class III · Macleods Pharma Usa Inc
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Lots: Lot #: BRD2001A, Exp 5/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Risedronic Acid: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA203533
- On the market since
- Dec 9, 2015
- Package NDCs
33342-107-0633342-107-0733342-107-49- Official label
- DailyMed (National Library of Medicine), updated Mar 1, 2026
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