NDC 67296-0578
Albuterol Sulfate 2.5 mg per 3 mL solution
On the label: RedPharm Drug. Inc.. It's repackaged: RedPharm Drug. Inc. rebottles it from Nephron Pharmaceuticals Corporation's NDC 0487-9501.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Nephron SC, LLC | West Columbia, SC, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 22, 2025 · 26 inspections, 10 with FDA action |
Repackaging site
- RedPharm Drug, Eden Prairie, MN, United States · repackages 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. - 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. - Oct 2, 2013 · Class II · Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Lots: Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15 - Jun 22, 2011 · Class II · Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility
Lots: Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
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
- solution
- Strength
- 2.5 mg per 3 mL
- Approval
- ANDA ANDA074880
- On the market since
- Sep 17, 1997
- Package NDCs
67296-0578-1- Official label
- DailyMed (National Library of Medicine), updated Jul 3, 2024
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