FDA recall D-1883-2019

Product

Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.

Reason for recall

Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-09-20

Report date

2019-10-09

Termination date

2022-08-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1883-2019