Drug Enforcement D-0225-2025

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

February 26, 2025

Termination Date

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Product Information

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
Product quantity
1330 bags
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed in PA

Location & Firm

Recalling firm
Fagron Compounding Services
Address
8710 E 34th St N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0225-2025
Event ID
96232
Recall initiation date
January 31, 2025
Center classification date
February 19, 2025
Code info
Lot # C274-000040409, Exp 03/22/2025
More code info
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