Azole Antifungal
Where is Terconazole made?
4 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 2 factories in Canada and the United States.
Canada 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.4 mg per 1 g, 8 mg per 1 g, 80 mg · NDC 51672-1304, 51672-1302, 51672-1330 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Cosette Pharmaceuticals, Inc.80 mg · NDC 0713-0552 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| E. FOUGERA & CO., A division of Nycomed US Inc. TerconazoleVaginal Cream 0.8%4 mg per 1 g, 8 mg per 1 g · NDC 0168-0346, 0168-0347 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd80 mg · NDC 45802-717 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Terconazole 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.
- A-S Medication Solutions:
50090-2341,50090-6266,50090-0917,50090-1901+2 - Dispensing Solutions Inc.:
55045-3259 - H.J. Harkins Co., Inc.:
52959-811 - NuCare Pharmaceuticals.Inc.:
68071-1626 - Physicians Total Care, Inc.:
54868-6160,54868-5183 - RPK Pharmaceuticals, Inc.:
53002-8130,53002-7240 - Rebel Distributors Corp..:
21695-844,21695-933
Recalls
- Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.