NDC 63187-964
Esomeprazole Magnesium 20 mg capsule, delayed release
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Dr. Reddy's Laboratories Inc.'s NDC 43598-509.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Recalls
- Apr 24, 2020 · Class III · Dr. Reddy's Laboratories, Inc.
Discoloration: product contains brown pellets
Lots: Lot #: C900642, Exp. 06/2020 - Feb 6, 2019 · Class III · Dr. Reddy's Laboratories, Inc.
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Lots: Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Esomeprazole: every company that makes it
- Form
- capsule, delayed release, oral
- Strength
- 20 mg
- Approval
- ANDA ANDA078279
- On the market since
- Dec 10, 2015
- Package NDCs
63187-964-3063187-964-6063187-964-90- Official label
- DailyMed (National Library of Medicine), updated Feb 1, 2023
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