NDC 63187-754
Tri-Lo-Marzia 6 ingredients kit
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-837.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Dhar, India | Makes it and packages it | Problems found, fixed voluntarilySep 27, 2024 · 4 inspections |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · relabels it
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: L001911 - Jan 10, 2020 · Class III · Lupin Pharmaceuticals Inc.
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Lots: Lot # L800498, exp. date February 2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ethinyl Estradiol and Norgestimate: every company that makes it
- Form
- kit
- Strength
- 6 ingredients
- Approval
- ANDA ANDA200541
- On the market since
- Jan 18, 2016
- Package NDCs
63187-754-28- Official label
- DailyMed (National Library of Medicine), updated Nov 1, 2019
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