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Class II · ModerateRecall completed

Difluprednate Ophthalmic Emulsion

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # DEG5BD2, Exp 07/2023
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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 to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forExelan Pharmecuticals, Inc., Boca Raton, FL 33432
NDC76282-708-50
Show the full FDA record
Full product labelDifluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
Recalling firmCIPLA
DistributionNationwide in the USA
Quantity3,468 bottles
Recall initiated2022-08-22
Report date2022-09-14
Recall completed2023-11-27
Recall numberD-1498-2022
ClassificationClass II
FDA statusTerminated
Origin on fileWarren NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.