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Class III · Lower riskRecall completed

Cequa

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot# 10026, Lot 10027, Exp. 09/2023.
Where it was soldNationwide wide 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

Subpotent: Out of Specification result observed for low assay

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

Made bySun Pharmaceutical Industries, Inc.
Brand nameCEQUA
Generic nameCYCLOSPORINE
Active ingredient(s)CYCLOSPORINE
Distributed by / forSun Pharma Global FZE by: Laboratoire Unither, Coutances, France
NDC47335-506-96
Show the full FDA record
Full product labelCequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide wide in the USA
Quantity69,707 cartons
Recall initiated2023-09-07
Report date2023-09-27
Recall completed2024-02-13
Recall numberD-1172-2023
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

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.