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FDAFDA · Food and drugs·Recall number D-1545-2022

Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.

Published October 5, 2022 · Recall initiated: September 15, 2022

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

Lack of Assurance of Sterility

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
BUDESONIDE
Manufacturer
CIPLA
Distributor
Nationwide in the USA and Puerto Rico
Lot
Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
Risk classification
Class II
Area (FDA)
drug
Country
United States

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