FDA recall D-1471-2022

Product

Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24

Reason for recall

Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2022-08-08

Report date

2022-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1471-2022