Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Recall Number: D-1883-2019
Firm: Akorn, Inc.
Classification: Class II
Status: Terminated
Report Date: 20191009
Initiation Date: 20190920
Termination Date: 20220801
Reason for Recall
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Product Description
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.