Antiarrhythmic, Cytochrome P450 2D6 Inhibitor
Where is Dextromethorphan and Quinidine made?
5 companies sell it under their own name and 1 repackager rebottle it. Their labels name 3 factories in Canada, India and the United States.
Canada 1India 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Avanir Pharmaceuticals, Inc. Nuedexta10 mg / 20 mg · NDC 64597-301 | Patheon Inc.Makes it, packages it and labels it | Mississauga, Canada | Problems found, fixed voluntarilyFeb 2023 |
| Camber Pharmaceuticals Inc.10 mg / 20 mg · NDC 31722-693 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.10 mg / 20 mg · NDC 63304-650 | Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 |
| Otsuka America Pharmaceutical, Inc. Nuedexta10 mg / 20 mg · NDC 59148-053 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.10 mg / 20 mg · NDC 0480-2602 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dextromethorphan and Quinidine 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.
- Golden State Medical Supply, Inc.:
84677-067
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
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.