Drug Recall: 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
Cipla USA, Inc. · June 30, 2025
Reason for Recall
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Product Description
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)
Distribution
Distributed Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
13,680 ampoules
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0541-2025
Status: ongoing
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