Reported Aug 17, 2022 · Terminated
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd.,…
Cipla
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CIPLA · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
- Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India
- Manufactured forCipla USA, Inc., NJ 07059, NDC 69097-341-35
- Lot codes and dates
Lot # DEG3LC2Exp 05/2023
- Amount recalled
- 7,992 bottles
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Complaints received of defective container closure.
This product could cause temporary or reversible health problems — stop using it.
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