FDAHealthJune 30, 2025
Cipla USA, Inc. — 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: C
⚠️ Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 30, 2025
Distributed Nationwide in the USA
What's affected?
- 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)
- Brand
- BUDESONIDE
- Lot code
- Batch # 4IA0505, Exp 09/31/2026
Additional details
Batch # 4IA0505, Exp 09/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 13,680 ampoules.
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