FDA recall D-0124-2017

Akorn Inc · Class II · drug

Product

Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.

Reason for recall

Subpotent Drug: concentration of product is less than labeled amount.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-10-21
Report date: 2016-11-09
Termination date: 2019-05-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0124-2017