Anticholinergic, beta2-Adrenergic Agonist
Where is Albuterol and Ipratropium made?
12 companies sell it under their own name and 5 repackagers rebottle it. Their labels name 6 factories in India and the United States.
India 4United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.0.5 mg per 3 mL / 2.5 mg per 3 mL · NDC 69097-840, 69097-173 | Cipla LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyJun 2024 |
| Cipla LimitedMakes it, tests it, packages it and labels it | Indore, India | Serious problems, FDA actionFeb 2023 | |
| The Ritedose CorporationMakes it, tests it, packages it and labels it | Columbia, SC, United States | Problems found, fixed voluntarilyFeb 2025 | |
| Aurobindo Pharma Limited0.5 mg per 3 mL / 2.5 mg per 3 mL · NDC 65862-906 | Eugia Pharma Specialities LimitedMakes it and tests it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Caraco Pharmaceutical Laboratories, Ltd.0.5 mg per 3 mL / 2.5 mg per 3 mL · NDC 47335-756 | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)Makes it and tests it | Halol Panchmahal, India | No problems foundFeb 2024 |
| Golden State Medical Supply, Inc.0.5 mg per 3 mL / 2.5 mg per 3 mL · NDC 60429-975 | The Ritedose CorporationMakes it | Columbia, SC, United States | Problems found, fixed voluntarilyFeb 2025 |
| Nephron Pharmaceuticals Corporation3 mg per 3 mL / 0.5 mg per 3 mL · NDC 0487-0201 | Nephron SC, LLCMakes it, tests it, packages it and labels it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 |
| Rising Pharma Holdings, Inc.3 mg per 3 mL / 0.5 mg per 3 mL · NDC 64980-645 | Nephron SC, LLCMakes it, tests it, packages it and labels it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 |
| American Health Packaging0.5 mg per 3 mL / 2.5 mg per 3 mL · NDC 60687-405 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Boehringer Ingelheim Pharmaceuticals, Inc. Combivent Respimat20 ug / 100 ug · NDC 0597-0024 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.3 mg per 3 mL / 0.5 mg per 3 mL · NDC 62135-831 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Medical Supply Distribution, Llc.3 mg per 3 mL / 0.5 mg per 3 mL · NDC 71152-201 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.5 mg per 3 mL / 2.5 mg per 3 mL · NDC 0378-9671 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ritedose Pharmaceuticals, LLC0.5 mg per 3 mL / 2.5 mg per 3 mL · NDC 76204-600 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Albuterol and Ipratropium 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:
50090-6288,50090-1382,50090-1669 - Physicians Total Care, Inc.:
54868-5974 - Preferred Pharmaceuticals, Inc..:
68788-8103 - Proficient Rx LP:
71205-726,71205-051 - RedPharm Drug. Inc.:
67296-2315,67296-0769
Recalls
- Mar 26, 2024 · Class II · Cipla USA, Inc.
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. - Apr 13, 2022 · Class III · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - Aug 21, 2015 · Class II · Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process - Jul 24, 2015 · Class II · Boehringer Ingelheim Roxane Inc
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.