NDC 71335-2101

Carvedilol 6.25 mg tablet, film coated

On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack 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

Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it

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.

Generic drug: Carvedilol: every company that makes it
Form: tablet, film coated, oral
Strength: 6.25 mg
Approval: ANDA ANDA077614
On the market since: Sep 5, 2007
Package NDCs: 71335-2101-1 71335-2101-2 71335-2101-3 71335-2101-4 71335-2101-5 71335-2101-6 71335-2101-7 71335-2101-8
Official label: DailyMed (National Library of Medicine), updated Aug 22, 2024

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