Reported May 3, 2017 · Terminated

Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only,…

Isomeric Pharmacy Solution, LLC

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: Isomeric Pharmacy Solution, LLC · 2401 S Foothill Dr Ste D · Salt Lake City, UT · 84109-1479

Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.

Lot codes and dates: Lot Numbers
10003
Exp 04/05/17
10018
Exp 04/17/17
10023
Exp 04/23/17
10025
Exp 04/24/17
10027
Exp 04/29/17
11011
11012
Exp 05/07/17
11024
11026
Exp 05/14/17
11029
Exp 05/16/17
11030
Exp 05/17/17
11032
Exp 05/21/17
11045
Exp 06/04/17
12008
Exp 06/13/17
12014
12015
Exp 06/20/17
12022
12024
Exp 06/28/17
13001
13002
Exp 07/03/17
13011
13012
Exp 07/09/17
Amount recalled: 5,165 bottles

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

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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