NDC 61919-157
Ramipril 5 mg capsule
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-590.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
| Lupin Limited | Chhatrapati Sambhajinagar, India | Makes it and packages it | Problems found, fixed voluntarilyMar 15, 2024 · 5 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it and relabels it
Recalls
- Oct 23, 2024 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lots: a) NDC 68180-589-09; Lots G326781, exp. date 30-Sep-25, GA04468, exp. date 31-May-25 b) NDC 68180-589-01; Lots G326763, exp. date 30-Sep-25, GA03041, exp. date 31-Mar-26, GA03725, exp. date 30-Apr-26, GA04402, exp. date 31-May-26, c) NDC 68180-589-02; Lots G326782, exp. date 30-Sep-25, … - Oct 23, 2024 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lots: a) NDC 68180-590-09; Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-25 - Oct 23, 2024 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lots: a) NDC 68180-591-09; Lots G327086, exp. date 30-Sep-25 GA01065, exp. date 31-Dec-25, b) NDC 68180-591-01 Lots G325033, G324987, exp. date 31-Jul-25, G325110, GA00956, GA01066, GA01126, exp. date 31-Dec-25, GA03299, GA03288, GA03287, exp. date 31-Mar-26 c) NDC 68180-591-02 Lot GA05919, exp. d…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ramiprilat: every company that makes it
- Form
- capsule
- Strength
- 5 mg
- Approval
- ANDA ANDA077626
- On the market since
- Jan 1, 2014
- Package NDCs
61919-157-30- Official label
- DailyMed (National Library of Medicine), updated Jan 21, 2020
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