NDC 53002-1799
Amlodipine Besylate and Benazepril Hydrochloride 5 mg / 10 mg capsule
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-339.
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
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Apr 9, 2012 · Class II · Dr. Reddy's Laboratories, Inc.
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Lots: C201293 Exp Date 08/2013
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Amlodipine and Benazeprilat: every company that makes it
- Form
- capsule
- Strength
- 5 mg / 10 mg
- Approval
- ANDA ANDA077183
- On the market since
- Apr 19, 2010
- Package NDCs
53002-1799-0- Official label
- DailyMed (National Library of Medicine), updated Aug 7, 2023
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