NDC 53002-1734
Alyacen 7/7/7 0.5 mg / 0.035 mg kit
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-556.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · relabels it
Recalls
- May 27, 2026 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Lots: Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
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 Norethindrone: every company that makes it
- Form
- kit
- Strength
- 0.5 mg / 0.035 mg
- Approval
- ANDA ANDA091636
- On the market since
- Jan 19, 2012
- Package NDCs
53002-1734-153002-1734-353002-1734-6- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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