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Class II · ModerateRecall completed

Moxifloxacin

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

Does this affect you?
Check your lot numberLot#: CMF210001, CMF210003, CMF210004, Exp 6/2023
Where it was soldUSA Nationwide
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

Failed Impurities/Degradation Specifications

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 byMade in India foreign manufacturer
Brand nameMOXIFLOXACIN
Generic nameMOXIFLOXACIN
Active ingredient(s)MOXIFLOXACIN HYDROCHLORIDE
Distributed by / forAurobindo Pharma USA, Inc., East Windsor, NJ 08520
NDC65862-840-03
Show the full FDA record
Full product labelMoxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03
Recalling firmAurobindo Pharma USA Inc.
DistributionUSA Nationwide
Quantity115776 bottles
Recall initiated2022-01-14
Report date2022-02-23
Recall completed2024-07-31
Recall numberD-0560-2022
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

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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.