FDA-Drug2019-10-09Class II
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Akorn, Inc.
Hazard
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
60,176 bottles
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1883-2019Don't want to check this manually?
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