NDC 72189-503
Prochlorperazine Maleate 10 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Jubilant Cadista Pharmaceuticals Inc.'s NDC 59746-115.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Havix Group Inc d/b/a Aavis Pharmaceuticals | Hoschton, GA, United States | Makes it | Problems found, fixed voluntarilyJul 25, 2025 · 2 inspections |
| Jubilant Generics Limited | Roorkee, India | Makes it | Problems found, fixed voluntarilyFeb 2, 2024 · 8 inspections, 3 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Dec 27, 2022 · Class III · Jubilant Cadista Pharmaceuticals, Inc.
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Lots: Lot#: 21P0336, Exp: 04/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Prochlorperazine: every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA040268
- On the market since
- Aug 3, 2023
- Package NDCs
72189-503-30- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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