December 2019 FDA Recall Drug by Akorn, Inc.
D-1388-2020 - Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

This Class III drug recall was voluntarily initiated by Akorn, Inc. on December 26, 2019 for the product Drug. The FDA reported the reason for recall as chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1388-2020

Reason for Recall
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Initiated
12-26-2019
Reported
07-22-2020
Quantity
33,343 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86019
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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 USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-28-2022
Product Description About Product Description
Full technical description of the product.
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12

Batch or Lot Expiration Information

Lot# Lot 9E52A, exp 04/2021