Histamine-1 Receptor Inhibitor, Histamine-1 Receptor Antagonist
Where is Olopatadine made?
8 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 4 factories in the United States, India and Japan.
United States 2India 1Japan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn1 mg per 1 mL, 2 mg per 1 mL · NDC 17478-105, 17478-305 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| Akorn665 ug · NDC 50383-943 | AkornMakes it and packages it | Location not on file | Not inspected on record |
| Alembic Pharmaceuticals Inc.1 mg per 1 mL, 2 mg per 1 mL · NDC 62332-501, 62332-502 | Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Amneal Pharmaceuticals665 ug · NDC 65162-890 | Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Branchburg, NJ, United States | No problems foundAug 2026 |
| H.J. Harkins Co., Inc.1.11 mg per 1 mL · NDC 76519-1161 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Sandoz Inc.665 ug per 100 uL · NDC 61314-320 | Kyowa Pharma Chemical Co., Ltd.Makes the active ingredient | Takaoka, Japan | Problems found, fixed voluntarilyDec 2022 |
| Apotex Corp.665 ug · NDC 60505-0845 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd665 ug · NDC 45802-104 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Olopatadine 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:
50090-3552,50090-3566 - Bryant Ranch Prepack:
63629-8434,72162-1390 - Physicians Total Care, Inc.:
54868-4528,54868-6222,54868-6049 - RPK Pharmaceuticals, Inc.:
53002-0510
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc. · 2 recall notices
CGMP Deviations:
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.