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Drug company (FDA labeler)

Alcon, Inc.

NDC labeler code: 0065

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

1Prescription medicines
1Products (NDC)
1FDA applications
6Recalls

Prescription medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
ApprovedApplicationMedicineSponsor
March 28, 2006NDA021980 Fluorescein
FLUORESCITE		Alcon Labs Inc

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2022

  1. April 13, 2022 · Class II · Terminated · D-1036-2022 · Carbachol

    cGMP deviations: Temperature abuse

    MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0023-15

  2. April 13, 2022 · Class II · Terminated · D-1113-2022 · Tetracaine hydrochloride

    cGMP deviations: Temperature abuse

    Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14

  3. April 13, 2022 · Class II · Terminated · D-1008-2022 · Povidone-iodine

    cGMP deviations: Temperature abuse

    Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical Inc., NDC 0065-0411-30

  4. April 13, 2022 · Class II · Terminated · D-1035-2022 · Atropine

    cGMP deviations: Temperature abuse

    Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55

  5. April 13, 2022 · Class II · Terminated · D-1033-2022 · Balanced salt solution

    cGMP deviations: Temperature abuse

    BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15

  6. April 13, 2022 · Class II · Terminated · D-1034-2022 · Balanced salt solution

    cGMP deviations: Temperature abuse

    BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-50

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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