Fluorescein Sodium And Proparacaine Hydrochloride Solution/ Drops
FDA Recall NDC 59390-205

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Fluorescein Sodium And Proparacaine Hydrochloride (NDC 59390-205). A significant event, classified as Class II, was initiated on Jul 02, 2019 by Altaire Pharmaceuticals Inc.. The reported reason for this action was: "Lack of Assurance of Sterility"

This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0422-2020COMPLETED

July 2019 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0422-2020
Class II Completed
Reason for Recall
Lack of Assurance of Sterility
Initiated
Jul 02, 2019
Reported
Nov 27, 2019
Quantity
532,961 units

Recall Profile & Regulatory Data

Event ID
83265
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-205-05
Batch or Lot Expiration Information
Lot# 17099 4/20 6/1/2017 17254 8/20 9/14/2017 17255 8/20 9/15/2017 17361 12/20 12/26/2017 17362 12/20 4/4/2018 18088 4/21 4/30/2018 18089 4/21 5/1/2018 18138 6/21 6/25/2018 18146 6/21 6/29/2018 18156 6/21 8/6/2018 18212 8/21 10/2/2018 18276 11/21 12/26/2018 19082 3/22 5/1/2019 19098 4/22 5/21/2019 16282 10/19 11/11/2016 16283 10/19
Affected Packages Involved in this Recall
59390-205-05Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.