Drug 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)
D-0541-2025
Product summary
- Firm
- Cipla USA, Inc.
- Event
- Event 97170
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13,680 ampoules
- Official record key
drug-enforcement:D-0541-2025
Official wording
Reason: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Code information: Batch # 4IA0505, Exp 09/31/2026
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility