NDC 52959-466
Carvedilol 6.25 mg tablet, film coated
On the label: H.J. Harkins Co., Inc.. It's repackaged: H.J. Harkins Co., Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-093.
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
- Strength
- 6.25 mg
- Approval
- ANDA ANDA077614
- On the market since
- Sep 5, 2007
- Package NDCs
52959-466-30- Official label
- DailyMed (National Library of Medicine), updated Nov 2, 2011
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