Ropivacaine 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 Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by:…

Recall number

D-0842-2023

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

Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs