Recall: D-0541-2025

Class II - Potentially Harmful

Class IIClassification

2025-06-30Initiated

OngoingStatus

Cipla USA, Inc.Firm

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

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.