October 2021 FDA Recall Drug by Akorn, Inc.
D-0004-2022 - Microbial Contamination of Sterile Products

This Class II drug recall was voluntarily initiated by Akorn, Inc. on October 4, 2021 for the product Drug. The FDA reported the reason for recall as microbial contamination of sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0004-2022

Reason for Recall
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Initiated
10-04-2021
Reported
10-13-2021
Quantity
10,210 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88823
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.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-17-2022
Product Description About Product Description
Full technical description of the product.
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11

Batch or Lot Expiration Information

Lot# Lot 0B61A, Exp 01/31/2022