FDA recall D-0577-2018

Akorn, Inc. · Class III · drug

Product

Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05

Reason for recall

Failed Stability Specification: OOS low viscosity results discovered during retain testing.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-02-21
Report date: 2018-03-14
Termination date: 2020-08-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0577-2018