FentaNYL 100 mcg/ Injection for IV or IM Use recalled over sterility concerns

Recall date

December 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SCA Pharmaceuticals recalls fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainb…

Recall number

D-0214-2021

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

Product was distributed to hospitals nationwide.

Why it was recalled

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006