Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution Recalled by Altaire Pharmaceuticals, Inc. Due to Lack of Assurance of Sterility

Date: July 2, 2019
Company: Altaire Pharmaceuticals, Inc.
Status: Completed
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Altaire Pharmaceuticals, Inc. directly.

Affected Products

OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21

Quantity: 427,280 units

Why Was This Recalled?

Lack of Assurance of Sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Altaire Pharmaceuticals, Inc.

Altaire Pharmaceuticals, Inc. has 135 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report