HYDROmorphone HCl 30 mg/ in 0 recalled over sterility concerns

Recall date

December 17, 2020

Source

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

Official notice title

SCA Pharmaceuticals recalls HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (bar…

Recall number

D-0196-2021

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

HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095