FDAClass IIAugust 17, 2022

Difluprednate Ophthalmic Emulsion 0.05% recall: Sterility Concern

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla…

Why was Difluprednate Ophthalmic Emulsion 0.05% recalled?

Lack of Assurance of Sterility: Complaints received of defective container closure.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # DEG3LC2, Exp 05/2023

Product
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla…
Recalling firm
CIPLA
Quantity
7,992 bottles
Distribution
Nationwide in the USA
Recall date
August 17, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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