DilTIAZem HCl in 5% Dextrose Injection recalled over sterility concerns

Recall date

November 12, 2021

Source

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

Official notice title

SterRx, LLC recalls dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburg…

Recall number

D-0315-2022

FDA classification

Class II

Brand / firm

SterRx, LLC

Sold / distributed

U.S.A. Nationwide

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

dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.