Drug Enforcement D-0541-2025

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Status

Ongoing

Classification

Class II

Report Date

July 30, 2025

Termination Date

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Product Information

Product description
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)
Product quantity
13,680 ampoules
Reason for recall
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed Nationwide in the USA

Location & Firm

Recalling firm
Cipla USA, Inc.
Address
10 Independence Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0541-2025
Event ID
97170
Recall initiation date
June 30, 2025
Center classification date
July 22, 2025
Code info
Batch # 4IA0505, Exp 09/31/2026
More code info
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