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Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL...

FDA Recall #D-0436-2019 — Class II — December 17, 2018

Recall #D-0436-2019 Date: December 17, 2018 Classification: Class II Status: Terminated

Product Description

Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

Reason for Recall

Lack of sterility assurance.

Recalling Firm

Promise Pharmacy, LLC — Palm Harbor, FL

Classification

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

Product Type

Drugs

Product Quantity

900 3 ml bottles

Distribution

Nationwide in the USA.

Code Information

Lots: 11012018@1 BUD: 1/14/2019; 11022018@1 BUD: 1/15/2019

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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