Class IICompleted

fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII recall

FDA recall D-0225-2025 · initiated Jan 31, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Lack of Assurance of Sterility

Details

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
Recalling company: Fagron Compounding Services
Classification: Class II
Status: Completed
Type: Voluntary: Firm initiated
Distribution: Distributed in PA
Initiated: Jan 31, 2025
FDA report date: Feb 26, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0225-2025 ↗

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