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EDTA 3% ophthalmic

FDA Recall #D-1111-2014 — Class II — November 1, 2013

Recall #D-1111-2014 Date: November 1, 2013 Classification: Class II Status: Terminated

Product Description

EDTA 3% ophthalmic

Reason for Recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Recalling Firm

Natures Pharmacy & Compounding Center — Asheville, NC

Classification

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

Product Type

Drugs

Distribution

NC

Code Information

All lot numbers within expiry.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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