Budesonide Inhalation Suspension 0 recalled over sterility concerns

Recall date

September 15, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CIPLA recalls Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules p…

Recall number

D-1545-2022

FDA classification

Class II

Brand / firm

CIPLA

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.