Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.

FDA recall notice · announced October 9, 2019 · Akorn

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: 031908A, Exp 03/20
Quantity: 60,176 bottles
Status: Terminated
Products in this recall event:
- Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15. (D-1883-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.