NDC 70518-1377
Carvedilol 3.125 mg tablet, film coated
On the label: Remedyrepack Inc.. It's repackaged: Remedyrepack Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-092.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
| Zydus Pharmaceuticals Limited | Matoda, India | Makes it and tests it | Not inspected on record |
Recalls
- Aug 13, 2021 · Class II · Zydus Pharmaceuticals (USA) Inc
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Lots: Z006279, exp 12/31/2022 - Apr 25, 2019 · Class II · Zydus Pharmaceuticals USA Inc
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Lots: Z804517, exp Nov 30, 2020 - Apr 22, 2019 · Class III · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Lots: Lot #: Z803518, Exp 08/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Carvedilol: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 3.125 mg
- Approval
- ANDA ANDA077614
- On the market since
- Aug 15, 2018
- Package NDCs
70518-1377-070518-1377-170518-1377-270518-1377-370518-1377-470518-1377-570518-1377-670518-1377-7- Official label
- DailyMed (National Library of Medicine), updated Jul 6, 2026
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