FDA-Drug2022-08-17Class II
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
CIPLA
Hazard
Lack of Assurance of Sterility: Complaints received of defective container closure.
Sold states
Nationwide in the USA
Affected count
7,992 bottles
Manufactured in
10 Independence Blvd, Warren, NJ, United States
Products
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1328-2022Don't want to check this manually?
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