Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by
Summary
The FDA issued a Class II for Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, by Cipla USA, Inc.. Reason: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule..
Details
Source
Drug Recall
External ID
D-0541-2025
Action Date
2025-07-30
Status
Ongoing
Category
drug
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)
Lot/Code Info: Batch # 4IA0505, Exp 09/31/2026
Quantity Affected: 13,680 ampoules
Reason for Recall
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-30
Company
Warren, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cipla USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cipla USA, Inc. have FDA actions?
Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0541-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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