FDA recall D-0410-2021

Cardinal Health Inc. · Class II · drug

Product

Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution

FL, GA, SC

Key facts

Status: Terminated
Initiation date: 2021-03-15
Report date: 2021-06-02
Termination date: 2024-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0410-2021