FDA recall D-0511-2019

Akorn Inc · Class II · drug

Product

Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.

Reason for recall

Failed Stability Specification: out of specification results for Sodium Perborate

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2019-02-04
Report date: 2019-02-27
Termination date: 2022-07-29
Voluntary/Mandated: —
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0511-2019