NDC 0487-0201
Ipratropium Bromide and Albuterol Sulfate 3 mg per 3 mL / 0.5 mg per 3 mL solution
On the label: Nephron Pharmaceuticals Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Nephron SC, LLC | West Columbia, SC, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyAug 22, 2025 · 26 inspections, 10 with FDA action |
Recalls
- Apr 13, 2022 · Class III · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. - Aug 21, 2015 · Class II · Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Lots: a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Albuterol and Ipratropium: every company that makes it
- Form
- solution, respiratory (inhalation)
- Strength
- 3 mg per 3 mL / 0.5 mg per 3 mL
- Approval
- ANDA ANDA076749
- On the market since
- Dec 31, 2007
- Package NDCs
0487-0201-010487-0201-020487-0201-030487-0201-60- Official label
- DailyMed (National Library of Medicine), updated May 8, 2026
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