Lupin Limited
Chhatrapati Sambhajinagar, India · makes it and packages it
Problems found, fixed voluntarily Last FDA inspection Mar 15, 2024. 5 inspections on record.
NDC 82804-164
Amlodipine Besylate 10 mg tablet
On the label: Proficient Rx LP.
It's a repackaged product: Proficient Rx LP rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-721.
Where the pills inside were made
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Recalls
- Jun 27, 2023 · Class III · Terminated
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Lots: Lot #: A102887, Exp. 6/2023 - Feb 19, 2016 · Class III · Terminated
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Lot #: G304799, Exp. 4/2016 - Feb 19, 2016 · Class III · Terminated
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016
Product details
- Generic drug
- Amlodipine: see every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA078043
- On the market since
- Aug 15, 2018
- Package NDCs
82804-164-90- Official label
- DailyMed (National Library of Medicine), updated Nov 1, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?