NDC 43547-312
Valsartan And Hydrochlorothiazide 160 mg / 12.5 mg tablet, film coated
On the label: Solco Healthcare U.S., LLC.
Where it's 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 |
Recalls
- 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.
Product details
- Generic drug
- Hydrochlorothiazide and Valsartan: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 160 mg / 12.5 mg
- Approval
- ANDA ANDA206083
- On the market since
- Oct 31, 2015
- Package NDCs
43547-312-0343547-312-0943547-312-50- Official label
- DailyMed (National Library of Medicine), updated Jul 31, 2025
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