Multi-event August 2022 FDA Recall Drug by Akorn, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Akorn, Inc. on August 31, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1495-2022 TERMINATED D-1496-2022 TERMINATED

Recall Number: D-1495-2022

Reason for Recall
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Initiated
08-31-2022
Reported
09-14-2022
Quantity
82,689 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90813
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.
USA nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-18-2024
Product Description About Product Description
Full technical description of the product.
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31

Batch or Lot Expiration Information

Lot# 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, Exp 8/31/2022; 9K62A, 9K62B, 9K62C, Exp 9/30/2022; 9M04A, 9M04B, Exp 11/30/2022

Recall Number: D-1496-2022

Reason for Recall
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Initiated
08-31-2022
Reported
09-14-2022
Quantity
48,636 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90813
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.
USA nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-18-2024
Product Description About Product Description
Full technical description of the product.
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35

Batch or Lot Expiration Information

Lot# : 9J58A, 9J58B, Exp 8/31/2022