May 2016 FDA Recall Drug by Akorn, Inc.
D-0949-2016 - Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability

This Class II drug recall was voluntarily initiated by Akorn, Inc. on May 17, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; some lots failed antimicrobial effectiveness testing on stability. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0949-2016

Reason for Recall
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Initiated
05-17-2016
Reported
06-08-2016
Quantity
57,920 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74099
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.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
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 and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-21-2017
Product Description About Product Description
Full technical description of the product.
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12

Batch or Lot Expiration Information

Lot# 5A17A, Expiry 06/16
Lot# 5K21A, Expiry 03/17
Lot# 6A08A, Expiry 06/17