Akorn, Inc. recalls Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL
Recalled October 9, 2019 · FDA recall D-1883-2019 · Akorn
Hazard
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product. · FDA Class II
Units
60,176 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
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.
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →