FDA-Drug2025-07-30Class II
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)
Hazard
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Sold states
Distributed Nationwide in the USA
Affected count
13,680 ampoules
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0541-2025More Cipla USA, Inc. recalls
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for N-nitroso impurity
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 90 mg tablets recalled for N-nitroso impurity above acceptable limits
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 60 mg tablets recalled for N-nitroso impurity above safe limits
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