FDA recall D-0799-2023

Product

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

Reason for recall

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

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Ongoing

Initiation date

2023-04-26

Report date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0799-2023