Class II
Ongoing
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)
This recall is currently active, issued July 30, 2025. It was issued by Cipla Usa, Inc..
- Company
- Cipla Usa, Inc.
- Recall Initiated
- June 30, 2025
- Posted
- July 30, 2025
- Recall Number
- D-0541-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,680 ampoules
- Firm Location
- Warren, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Batch # 4IA0505, Exp 09/31/2026
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