Reported Nov 27, 2019 · Completed

OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only,…

Altaire Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Altaire Pharmaceuticals, Inc. · 311 W Ln · Aquebogue, NY · 11931-0849

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

Lot codes and dates: 17255
8/20
17362
12/20
18089
4/21
18138
6/21
6/22/2018
18146
6/21
18210
8/21
18211
8/21
18272
11/21
18273
11/21
18276
11/21
16283
10/31/2019
Amount recalled: 427,280 units

The agency filed one notice per product. You are reading one of them; the other 133 are below.

121 more are in the archive.

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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