October 10, 2019
A lack of sterility assurance has prompted Akorn Inc. to recall more than 60,000 bottles of phenylephrine hydrochloride ophthalmic solution, 2.5%. According to the October 9, 2019, US Food and Drug Administration (FDA) Enforcement Report, the recall announcement followed “out-of-specification results for [the] container closure test, which cannot guarantee the sterility of the product.”
The recall affects 15-mL bottles of phenylephrine hydrochloride ophthalmic solution (NDC 17478-201-15) from lot 031908A (Exp. 3/20). The bottles were distributed throughout the United States and Puerto Rico.
Akorn voluntarily initiated the recall September 20, 2019. The FDA designated the recall Class II on September 30, 2019. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Phenylephrine hydrochloride is a prescription ophthalmic solution used to constrict blood vessels in the eye and to dilate pupils.