Mast Cell Stabilizer
Where is Cromolyn made?
9 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 2 factories in India and the United States.
India 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn40 mg per 1 mL · NDC 17478-291 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| Micro Labs Limited100 mg per 5 mL · NDC 42571-132 | Micro Labs LimitedMakes it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Rising Pharma Holdings, Inc.100 mg per 5 mL · NDC 16571-600 | Woodstock Sterile Solutions, Inc.Makes it, tests it and packages it | Woodstock, IL, United States | No problems foundOct 2022 |
| Ailex Pharmaceuticals, LLC20 mg per 2 mL, 100 mg per 5 mL · NDC 70556-101, 70556-102 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Omnivium Pharmaceuticals Llc.100 mg per 5 mL · NDC 81665-104 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ritedose Pharmaceuticals, LLC20 mg per 2 mL, 100 mg per 5 mL · NDC 76204-025, 76204-028 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.40 mg per 1 mL · NDC 61314-237 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.20 mg per 2 mL · NDC 0172-6406 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Viatris Specialty LLC Gastrocrom20 mg per 1 mL · NDC 0037-0678 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Cromolyn 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:
50090-1202 - Preferred Pharmaceuticals, Inc..:
68788-8490 - Proficient Rx LP:
71205-230 - RPK Pharmaceuticals, Inc.:
53002-0140
Recalls
- Jul 21, 2023 · Class II · The Ritedose Corporation
CGMP deviation: product released prior to supplier approval. - Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations:
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.