Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10

FDA recall notice · announced February 6, 2019 · Akorn

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

The product

Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10

Reason for recall

Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
Quantity: 149,159 5mL bottles
Status: Terminated
Products in this recall event:
- Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10 (D-0414-2019)

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