Product: Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
Reason for recall: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Recall initiated: 20250630
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated