February 2019 FDA Recall Drug by Akorn Inc
D-0511-2019 - Failed Stability Specification

This Class II drug recall was initiated by Akorn Inc on February 4, 2019 for the product Drug. The FDA reported the reason for recall as failed stability specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0511-2019

Reason for Recall
Failed Stability Specification: out of specification results for Sodium Perborate
Initiated
02-04-2019
Reported
02-27-2019
Quantity
78120 dropper bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akorn Inc
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2022
Product Description About Product Description
Full technical description of the product.
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.

Batch or Lot Expiration Information

Lot# 8D31A, Exp: 03/20; 7H98A, Exp: 07/19; 7L80A, Exp: 10/19.