CIPLA recalls Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules pe
Recalled October 5, 2022 · FDA recall D-1545-2022 · CIPLA
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
641,160 ampules
Sold at
Nationwide in the USA and Puerto Rico
Description
Lack of Assurance of Sterility
Product
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.
Manufacturer(s)
CIPLA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →