Angiotensin 2 Receptor Blocker, Thiazide Diuretic
Where is Hydrochlorothiazide and Irbesartan made?
10 companies sell it under their own name and 5 repackagers rebottle it. Their labels name 9 factories in India, France, the United States, China, Italy and Hungary.
India 3France 2United States 1China 1Italy 1Hungary 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sanofi-Aventis U.S. LLC Avalide150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 0024-5855, 0024-5856 | Cambrex Profarmaco Milano SRLMakes the active ingredient and tests it | Paullo, Italy | No problems foundNov 2022 |
| EUROAPI Hungary Ltd.Makes the active ingredient and tests it | Budapest, Hungary | No problems foundJun 2019 | |
| Sanofi Winthrop IndustrieMakes it and tests it | Ambares Et Lagrave, France | Problems found, fixed voluntarilyNov 2023 | |
| Sanofi Winthrop IndustrieMakes the active ingredient and tests it | Aramon, France | Problems found, fixed voluntarilyMar 2023 | |
| Alembic Pharmaceuticals Inc.25 mg / 300 mg, 150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 62332-051, 62332-053, 62332-052 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited25 mg / 300 mg, 150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 46708-442, 46708-444, 46708-443 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited25 mg / 300 mg, 150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 65862-629, 65862-631, 65862-630 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Hikma Pharmaceuticals USA Inc.25 mg / 300 mg, 150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 0054-0254, 0054-0256, 0054-0255 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Hisun Pharmaceuticals USA Inc.150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 42658-141, 42658-142 | Hanhui Pharmaceuticals Co., Ltd.Makes it | Hangzhou, China | No problems foundMar 2025 |
| Macleods Pharmaceuticals Limited150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 33342-057, 33342-058 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 |
| Solco Healthcare U.S., LLC150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 43547-330, 43547-331 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 0093-8238, 0093-8232 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.150 mg / 12.5 mg, 300 mg / 12.5 mg · NDC 29300-215, 29300-216 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydrochlorothiazide and Irbesartan in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Bryant Ranch Prepack:
63629-7468,71335-1392,72162-2317,72162-1035+3 - Legacy Pharmaceutical Packaging:
68645-405 - Physicians Total Care, Inc.:
54868-4494,54868-6457,54868-5465,54868-4526 - Proficient Rx LP:
63187-981,63187-653,71205-063 - Remedyrepack Inc.:
70518-3593,70518-1550
Recalls
- Jan 18, 2019 · Class II · Prinston Pharmaceutical Inc · 4 recall notices
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. - May 30, 2016 · Class III · Prinston Pharmaceutical Inc
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container. - Oct 20, 2015 · Class III · Teva Pharmaceutical Industries
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.