Dicyclomine Hydrochloride Injection USP recalled over manufacturing violations

Recall date

April 26, 2023

Source

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

Official notice title

Akorn, Inc. recalls Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Op…

Recall number

D-0799-2023

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

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

What was recalled

Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs