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.
Recall initiated: 20190920
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated