Class IIReported 2025-07-30

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 Number

D-0541-2025

Classification

Class II

Status

Ongoing