Isomeric Pharmacy Solution, LLC recalls Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric

Recalled May 3, 2017 · FDA recall D-0687-2017 · Isomeric Pharmacy Solution

Hazard

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

Units

5,165 bottles

Sold at

Nationwide in the USA and Puerto Rico

Description

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

Product

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.

Manufacturer(s)

Isomeric Pharmacy Solution, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →