October 2018 FDA Recall Drug by Akorn, Inc.
D-0414-2019 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Akorn, Inc. on October 8, 2018 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0414-2019
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
10-08-2018
02-06-2019
149,159 5mL bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akorn, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA and Puerto Rico
06-15-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
