Phenylephrine 2 recalled over sterility concerns

Recall date

April 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0687-2017

FDA classification

Class II

Brand / firm

Isomeric Pharmacy Solution, LLC

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.