NDC 33342-033
Pramipexole dihydrochloride 0.5 mg tablet
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
- Aug 21, 2019 · Class III · Macleods Pharma Usa Inc
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Lots: Lot #BPA801A, EXP 12/2020 - Dec 24, 2015 · Class II · Macleods Pharma Usa Inc
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Lots: Lot #: BPA512A; Expiry: 06/2017.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pramipexole: every company that makes it
- Form
- tablet, oral
- Strength
- 0.5 mg
- Approval
- ANDA ANDA202164
- On the market since
- Sep 21, 2012
- Package NDCs
33342-033-0633342-033-1033342-033-1233342-033-15- Official label
- DailyMed (National Library of Medicine), updated Oct 15, 2025
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