September 2021 FDA Recall Theratears Extra by Akorn, Inc.
D-0717-2022 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Akorn, Inc. on September 8, 2021 for the product Theratears Extra. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0717-2022
Lack of Assurance of Sterility
09-08-2021
03-30-2022
62,331 box
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 within theUSA
09-28-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30
Batch or Lot Expiration Information
Lot# : 913012, 913013, 913014, Exp. Date 1/31/2023
