Cholinergic Muscarinic Antagonist
Where is Darifenacin made?
9 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 6 factories in India and the United States.
India 5United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Inc.7.5 mg, 15 mg · NDC 62332-224, 62332-223 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited7.5 mg, 15 mg · NDC 46708-224, 46708-223 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited7.5 mg, 15 mg · NDC 65862-862, 65862-861 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cipla USA., Inc.7.5 mg, 15 mg · NDC 69097-432, 69097-431 | Cipla LimitedMakes it, tests it, packages it and labels it | Raigad, India | Problems found, fixed voluntarilyApr 2024 |
| Macleods Pharmaceuticals Limited7.5 mg, 15 mg · NDC 33342-277, 33342-276 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Rising Pharma Holdings, Inc.7.5 mg, 15 mg · NDC 16571-768, 16571-767 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Torrent Pharma, Inc.7.5 mg, 15 mg · NDC 13668-203, 13668-202 | Torrent Pharmaceuticals LimitedMakes it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Xiromed, LLC.7.5 mg, 15 mg · NDC 70700-183, 70700-182 | Bostal LLCMakes it, tests it, packages it and labels it | Edison, NJ, United States | Problems found, fixed voluntarilyDec 2024 |
| Alan Laboratories, Inc.7.5 mg, 15 mg · NDC 70754-162, 70754-161 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Darifenacin 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:
72162-2571,72162-2570 - Physicians Total Care, Inc.:
54868-5363,54868-5704
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc. · 2 recall notices
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.