NDC 21695-394
Quinapril 10 mg tablet
On the label: Rebel Distributors Corp... It's repackaged: Rebel Distributors Corp.. rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-557.
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 |
Recalls
- Dec 7, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Lots: Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024 - Dec 7, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Lots: Lot #: G102929, Exp 04/2023 - Dec 7, 2015 · Class III · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications; Impurity A
Lots: Batch number G303703, exp 3/2016 - Sep 17, 2013 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Lots: Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13 - Sep 17, 2013 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Lots: Lot 3110358 Exp. 12/13
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Quinapril: every company that makes it
- Form
- tablet
- Strength
- 10 mg
- Approval
- ANDA ANDA077690
- On the market since
- Feb 26, 2010
- Package NDCs
21695-394-30- Official label
- DailyMed (National Library of Medicine), updated Jan 4, 2011
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