Difluprednate Ophthalmic Emulsion recall: Sterility Concern
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna…
Why was Difluprednate Ophthalmic Emulsion recalled?
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
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?
Batch# DEG4LC2, exp. date 05/2023
- Product
- Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna…
- Recalling firm
- CIPLA
- Quantity
- 8,136 bottles
- Distribution
- Nationwide in the USA
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)