FDARecalled Jul 30, 2025 · #D-0541-2025
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. ...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. Classification: Class II Distribution: Distributed Nationwide in the USA
Product details
- 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)
- Type
- Drugs
- Manufacturer
- Cipla USA, Inc.
- Model numbers
- —
- UPCs
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