fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services
Summary
The FDA issued a Class II for fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single us by Fagron Compounding Services. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0225-2025
Action Date
2025-02-26
Status
Completed
Category
drug
Product Description
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Lot/Code Info: Lot # C274-000040409, Exp 03/22/2025
Quantity Affected: 1330 bags
Reason for Recall
Lack of Assurance of Sterility
Distribution
Distributed in PA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-31
Company
Wichita, KS
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 53 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fagron Compounding Services has 10 FDA actions in our database, including 10 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 (Fagron Compounding Services) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fagron Compounding Services have FDA actions?
Fagron Compounding Services has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0225-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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