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5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations...

FDA Recall #D-0190-2023 — Class II — December 22, 2022

Recall #D-0190-2023 Date: December 22, 2022 Classification: Class II Status: Terminated

Product Description

5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason for Recall

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Recalling Firm

Pharmacy Innovations — Erie, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

Nationwide in the USA

Code Information

t20221019@52 t20221013@13

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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