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

FDA Recall #D-0363-2023 — Class III — February 24, 2023

Recall #D-0363-2023 Date: February 24, 2023 Classification: Class III Status: Terminated

Product Description

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.

Reason for Recall

Subpotent Drug

Recalling Firm

SCA Pharmaceuticals — Windsor, CT

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

2125 syringes

Distribution

Nationwide in the US.

Code Information

Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated