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
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Classification
Class II
Status
Ongoing
Lot
Batch # 4IA0505, Exp 09/31/2026
Date
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