FDA-Drug2026-04-22Class II
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Nephron SC, LLC
Hazard
Labelling: Illegible label
Sold states
Nationwide within the United States
Affected count
146,280 vials
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0479-2026Original summary
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05. Labelling: Illegible label Lot AB6001, exp date 1/15/2027 Distribution: Nationwide within the United States Affected quantity: 146,280 vials
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