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Drug company (FDA labeler)

Altaire Pharmaceuticals Inc.

NDC labeler code: 59390

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

4Prescription medicines
4Products (NDC)
4FDA applications
6Recalls

Prescription medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
May 3, 2018ANDA204613 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE		Altaire Pharms Inc
December 14, 2017NDA208582 Fluorescein sodium and benoxinate hydrochloride
ALTAFLUOR BENOX		Altaire Pharms Inc
November 16, 2015ANDA203383 Diclofenac
DICLOFENAC SODIUM		Altaire Pharms Inc
April 29, 2013ANDA202692 Ofloxacin
OFLOXACIN		Altaire Pharms Inc

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

Recall timeline

2019

  1. July 2, 2019 · Class II · Completed · D-0436-2020 · Ofloxacin

    Lack of Assurance of Sterility

    Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05

  2. July 2, 2019 · Class II · Completed · D-0461-2020 · Diclofenac

    Lack of Assurance of Sterility

    Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05

  3. July 2, 2019 · Class II · Completed · D-0419-2020 · Ciprofloxacin

    Lack of Assurance of Sterility

    Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire Pharmaceuticals, Inc Aquebogue, NY 11931 NDC 59390-217-02

  4. July 2, 2019 · Class II · Completed · D-0420-2020 · Ciprofloxacin

    Lack of Assurance of Sterility

    Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10

  5. July 2, 2019 · Class II · Completed · D-0478-2020 · Ciprofloxacin

    Lack of Assurance of Sterility

    Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05

  6. July 2, 2019 · Class II · Completed · D-0421-2020 · Diclofenac

    Lack of Assurance of Sterility

    Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-02

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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