HYDROmorphone HCl 10 mg/ in 0 recalled over sterility concerns

Recall date

November 9, 2023

Source

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

Official notice title

SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only…

Recall number

D-0407-2024

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility

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 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022