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.
Reason for recall: Lack of Assurance of Sterility
Recall initiated: 20220915
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated