Angiotensin 2 Receptor Blocker, Thiazide Diuretic
Where is Candesartan and Hydrochlorothiazide made?
5 companies sell it under their own name and 1 repackager rebottle it. Their labels name 2 factories in India.
India 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cadila Healthcare Limited16 mg / 12.5 mg, 25 mg / 32 mg, 32 mg / 12.5 mg · NDC 70771-1325, 70771-1327, 70771-1326 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Macleods Pharmaceuticals Limited16 mg / 12.5 mg, 25 mg / 32 mg, 32 mg / 12.5 mg · NDC 33342-131, 33342-133, 33342-132 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 |
| ANI Pharmaceuticals, Inc. Atacand HCT16 mg / 12.5 mg, 25 mg / 32 mg, 32 mg / 12.5 mg · NDC 62559-660, 62559-650, 62559-662 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.16 mg / 12.5 mg, 25 mg / 32 mg, 32 mg / 12.5 mg · NDC 0378-3001, 0378-3003, 0378-3002 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solco Healthcare U.S., LLC16 mg / 12.5 mg, 25 mg / 32 mg, 32 mg / 12.5 mg · NDC 43547-459, 43547-461, 43547-460 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Candesartan and Hydrochlorothiazide 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.
- Physicians Total Care, Inc.:
54868-4729,54868-4869
Recalls
- Oct 2, 2020 · Class III · Mylan Pharmaceuticals Inc.
Out-of-specification organic impurity results obtained during routine stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.