Recalls / Class II

Class IID-0225-2025

Product

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

Affected lot / code info

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

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Fagron Compounding Services

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

8710 E 34th St N, N/A, Wichita, Kansas 67226-2636

Distribution

Quantity

1330 bags

Distribution pattern

Distributed in PA

Timeline

Recall initiated

2025-01-31

FDA classified

2025-02-19

Posted by FDA

2025-02-26

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0225-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.