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Class III · Lower riskRecall completed

Neomycin And Polymyxin B Sulfates And Dexamethasone

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

Does this affect you?
Check your lot numberLot #s: 287880F, 287881F, Exp. 10/31/2019; 290555F, Exp. 11/30/2019; 293389F, Exp. 2/29/2020; 290556F, 290557F, 293386F, 293387F, Exp. 3/31/2020; 293388F, 293390F, Exp. 5/31/2020; 293391F, Exp. 6/30/2020; 293392F, Exp. 7/31/2020; 295342F, 298823F, Exp. 8/31/2020; 295344F, 295345F, 295346F, Exp. 10/31/2020; 295347F, 304496F, Exp. 11/30/2020; 298825F, Exp. 12/31/2020; 304495F, 304497F, Exp. 01/31/2021; 304963F, Exp. 3/31/2021; 304966F, Exp. 4/30/2021; 304964F, Exp. 5/31/2021.
Where it was soldNationwide in the U.S.
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

Labeling: Incorrect or missing package insert.

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 byAlcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540
Brand nameNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Generic nameNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE
Active ingredient(s)DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Distributed by / forSandoz Inc
NDC61314-630-06
Show the full FDA record
Full product labelNeomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06
Recalling firmSandoz Inc
DistributionNationwide in the U.S.
Quantity346,929 bottles
Recall initiated2019-10-17
Report date2019-11-06
Recall completed2022-01-19
Recall numberD-0162-2020
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.