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FDAFDA · Food and drugs·Recall number D-0580-2021

Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Published June 2, 2021 · Recall initiated: March 15, 2021

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
LEVALBUTEROL TARTRATE HFA INHALATION
Manufacturer
Cardinal Health Inc.
Distributor
FL, GA, SC
Lot
200093
Risk classification
Class II
Area (FDA)
drug
Country
United States

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