FDA-Drug2022-09-14Class II
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
CIPLA
Hazard
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.
Sold states
Nationwide in the USA
Affected count
3,468 bottles
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1498-2022Don't want to check this manually?
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