NDC 71335-2618

Valsartan And Hydrochlorothiazide 80 mg / 12.5 mg tablet, film coated

On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Solco Healthcare U.S., LLC's NDC 43547-311.

Where the pills inside were made

Factory	Where	Role	Last FDA inspection
Zhejiang Huahai Pharmaceutical Co., Ltd.	Linhai, China	Makes it	Serious problems, FDA actionApr 24, 2026 · 8 inspections, 3 with FDA action
Zhejiang Huahai Pharmaceutical Technology Co., Ltd.	Taizhou, China	Makes it	Problems found, fixed voluntarilyAug 22, 2025 · 1 inspection

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

Jul 13, 2018 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots: All lots within expiry.
Jul 13, 2018 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots: All lots within expiry.
Jul 13, 2018 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots: All lots within expiry
Jul 13, 2018 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots: All lots within expiry.
Jul 13, 2018 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots: All lots within expiry.

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Hydrochlorothiazide and Valsartan: every company that makes it
Form: tablet, film coated, oral
Strength: 80 mg / 12.5 mg
Approval: ANDA ANDA206083
On the market since: Oct 31, 2015
Package NDCs: 71335-2618-1 71335-2618-2
Official label: DailyMed (National Library of Medicine), updated May 29, 2025

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