NDC 82804-036
Albuterol Sulfate 108 ug aerosol, metered
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Sandoz Inc.'s NDC 0781-7296.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Kindeva Drug Delivery L.P. | Northridge, CA, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyNov 13, 2025 · 12 inspections |
| Kindeva Drug Delivery Limited | Loughborough, United Kingdom | Makes it | Problems found, fixed voluntarilyMar 14, 2025 · 8 inspections |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · relabels it
Recalls
- Apr 13, 2022 · Class II · 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.
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: every company that makes it
- Form
- aerosol, metered, respiratory (inhalation)
- Strength
- 108 ug
- Approval
- NDA authorized generic NDA020503
- On the market since
- Mar 15, 2021
- Package NDCs
82804-036-67- Official label
- DailyMed (National Library of Medicine), updated Oct 1, 2023
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