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Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 U...

FDA Recall #D-0239-2019 — Class III — October 18, 2018

Recall #D-0239-2019 Date: October 18, 2018 Classification: Class III Status: Terminated

Product Description

Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

Reason for Recall

Presence of precipitate

Recalling Firm

Promise Pharmacy LLC — Palm Harbor, FL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

U.S.A. Nationwide.

Code Information

Lot#: 04092018@2, Exp 12/03/2018

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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