Reported Nov 27, 2019 · Completed

Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx…

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

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

Lot codes and dates: 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
Amount recalled: 532,961 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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