FDA-Drug2022-10-05Class II
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.
CIPLA
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA and Puerto Rico
Affected count
641,160 ampules
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1545-2022Don't want to check this manually?
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