FDA recall D-0848-2023

Akorn, Inc. · Class II · drug

Product

Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured 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-0848-2023