NDC 0487-9501

Albuterol Sulfate 2.5 mg per 3 mL solution

Where it's 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

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.

Generic drug: Albuterol: every company that makes it
Form: solution, respiratory (inhalation)
Strength: 2.5 mg per 3 mL
Approval: ANDA ANDA074880
On the market since: Sep 17, 1997
Package NDCs: 0487-9501-01 0487-9501-03 0487-9501-25 0487-9501-60
Official label: DailyMed (National Library of Medicine), updated May 8, 2026

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