← FDA ENFORCEMENT
D-0225-2025Class II

Fagron Compounding Services

Recalling firm
Fagron Compounding Services
Product type
Drug
Status
Completed
Report date
2025-02-26
Distribution
Distributed in PA
Firm state
KS
Product quantity
1330 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

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

Code / lot info

Lot # C274-000040409, Exp 03/22/2025

Other recalls SPEQ maps to Environmental Monitoring
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.