Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules pe
Summary
The FDA issued a Class II for Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 env by CIPLA. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-1545-2022
Action Date
2022-10-05
Status
Terminated
Category
drug
Product Description
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
Lot/Code Info: Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
Quantity Affected: 641,160 ampules
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-15
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 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
CIPLA has 40 FDA actions in our database, including 7 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) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CIPLA have FDA actions?
CIPLA has 40 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1545-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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