US Drug Recall Register
Class III · Low risk Terminated Initiated Feb 24, 2023 (4 years ago)

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Subpotent Drug

What was recalled

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.

Recalling firm
SCA Pharmaceuticals
NDC code
70004-0200-16
Origin
CT, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0363-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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