CLASS II Drug recall · Reported 27 Nov 2019 · FDA Enforcement Report

iSolutions Nano Tears TF Clear Emollient Lubricant Gel recalled

Altaire Pharmaceuticals is recalling iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild, distributed nationwide in the US. The recall was initiated on 2 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 17366, Exp 12/19
Quantity recalled4409 units

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0434-2020
FDA event ID
83265
Recalling firm
Altaire Pharmaceuticals, Aquebogue, NY
Classification
Class II
Status
Completed
Recall initiated
2 Jul 2019
FDA classified
15 Nov 2019
Reported
27 Nov 2019
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Sterility

Timeline

2 Jul 2019Recall initiated by company
15 Nov 2019Classified by FDA+136 days
27 Nov 2019Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild Sterile, 0.5 FL OZ (15 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-13

Where it was distributed

U.S.A. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot #: 17366, Exp 12/19

Where was it sold?

U.S.A. Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 83265

This product is part of a recall event; the main page for the event is CVS Health Redness Relief Lubricant Redness Reliever Eye recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IICVS Health Redness Relief Lubricant Redness Reliever Eye recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIEquate Support Advanced Twin Pack recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Fast Acting Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Overnight Lubricating Eye Ointment, Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IITRP Pink Eye Relief recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IIPerrigo Bacitracin Ophthalmic Ointment recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Lubricant Eye Drops Advanced Relief recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IITRP Blur Relief recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IIAccutome Rx Accu-WASH recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT Homatropine Hydrobromide Ophthalmic Solution recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Preservative Free Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIiSolutions Nano Tears TF Clear Emollient Lubricant Gel recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIEquate Support Harmony Lubricant Eye Drops, Restores Tears recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Diclofenac Sodium Opthalmic Solution recalledDiclofenacAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Dry Eye Relief Lubricant Eye Drops, Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIiSolutions Nano Tears XP Clear Emollient Lubricant Gel recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIActivEyes Sterile Altalube Ointment recalled by Altaire PharmaceuticalsAltalubeAltaire PharmaceuticalsSterilityNationwide
CLASS IIEquate Restore PM Nighttime Lubricant Eye Ointment, Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIPolycin (bacitracin zinc and polymyxin B sulfate) recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIClear Eyes Redness Relief (Little Drug),Product Size recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IINatural Ophthalmics Ortho-K Thin Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIWalgreen's Lubricant Eye Ointment recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IINano Tears TF Clear Emollient Lubricant Gel Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IINatural Ophthalmics Women's Tear Stimulation Dry Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IINano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent recalledGoniotaireAltaire PharmaceuticalsSterilityNationwide
CLASS IIFreshKote Lubricant Eye Drops, Product Size recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIActivEyes Preservative Free Multi-Dose Lubricant Gel Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Preservative Free Lubricant Eye Drops Dry Eye recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT retaine NaCl Ophthalmic Ointment, Product Size recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIPerrigo Sterile Neo-Polycin HC (neomycin recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT retaine NaCl Sodium Chloride Hypertonicity recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOcusoft Tears Again Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Redness Relief Lubricant Redness Reliever Eye recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIiSolutions Nano Tears MO Clear Emollient Lubricant Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Homatropaire Homatropine Hyrdobromide Opthalmic recalledHomatropine Hydrobromide OphthalmicAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Sterile Eye Wash, Altaire Pharmaceuticals recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOfloxacin Ophthalmic Solution recalled by Altaire PharmaceuticalsOfloxacin OphthalmicAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Ciprofloxacin Ophthalmic Solution recalledCiprofloxacin Hcl OphthalmicAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Preservative Free Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Extra Strength Lubricant Gel Drops, Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IINatural Ophthalmics Cataract Eye Drops with Cineraria recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Lubricant Eye Ointment, Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Dry Eye Relief Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Ciprofloxacin HCl Ophthalmic Solution recalledCiprofloxacin Hcl OphthalmicAltaire PharmaceuticalsSterilityNationwide
CLASS IIActivEyes Lubricant Eye Ointment Preservative Free, Product Size recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIPuralube Ophthalmic Ointment recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Extra Strength Lubricant Gel Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIEquate Sterile Lubricant Stye Ointment recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT Tears Again Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IINatural Ophthalmics Tear Stimulation Forte Dry Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIPerrigo Neo-Polycin neomycin and polymixin B sulfates recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT Tears Again Sterile Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIPuralube Ointment Petrolatum Ophthalmic Ointment recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Lubricating Gel Drops for Anytime Use recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Fluorescein Sodium with Proparacaine Hydrochloride recalledFluorescein Sodium And Proparacaine HydrochlorideAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Preservative Free Lubricant Eye Drops Fast Acting recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IINano Tears MXP Forte Clear Emollient Lubricant Gel Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT Eye Wash Sterile Isotonic recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IIEquate Eye Allergy Relief Drops recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IIActivEyes Preservative Free Multi-Dose Lubricant Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIClear Eyes Redness Relief, Product Size recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIEquate Support Advanced Lubricating Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT Flucaine Proparacaine Hydrochloride recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Redness Relief Lubricant Redness Reliever Eye recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIPerrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IITRP Stye Relief recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Preservative Free Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIEquate Night & Day Restore Tears Lubricant Eye Pack recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Preservative Free Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIiSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IILubricant Eye Drops Moisturizing Twin Pack Walgreens recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT retaine NaCl Sodium Chloride Hypertonicity recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Multi-Action Relief Drops recalled by Altaire PharmaceuticalsAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Preservative Free Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Dry Eye Relief Lubricant Eye Drops, Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Preservative Free Lubricant Eye Drops Sensitive Solution recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IINano Tears MXP Forte Clear Emollient Lubricant Gel Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Maximum Redness Relief Lubricant Redness recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Diclofenac Sodium Opthalmic Solution recalledDiclofenacAltaire PharmaceuticalsSterilityNationwide
CLASS IIPuralube Petrolatum Ophthalmic Ointment recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Ciprofloxacin Ophthalmic Solution recalledCiprofloxacin Hcl OphthalmicAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Lubricant Eye Drops Multi-Symptom Eye Relief recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIEquate Support Advanced Lubricant Gel Drops Multi Dose recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT retaine NaCl Ophthalmic Ointment, Product Size recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IINatural Ophthalmics Ortho-K Thick Comfort Gel recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIGrandall Colirio Ojo De Aguila Eye Drops, Sterile recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIAltaire Sterile Eye Wash, Altaire Pharmaceuticals recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIWalgreens Sodium Chloride Ophthalmic Ointment recalledWalgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Preservative Free Lubricant Eye Drops recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIActivEyes Altachlore Sodium Chloride Hypertonicity recalledAltachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentAltaire PharmaceuticalsSterilityNationwide
CLASS IICVS Health Lubricating Gel Drops for Anytime Use recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIOCuSOFT Eye Wash Sterile Isotonic Buffered Solution recalledAltaire PharmaceuticalsSterilityNationwide
CLASS IIiSolutions ActivEyes Nighttime Lubricant Eye Ointment recalledAltaire PharmaceuticalsSterilityNationwide

More recalls from Altaire Pharmaceuticals

All 135
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIAltacaine (Tetracaine Hydrochloride) Ophthalmic Solution recalledAltaire PharmaceuticalsSterilityNationwide
DrugCLASS IIAltaire Sterile Eye Wash, Altaire Pharmaceuticals recalledAltaire PharmaceuticalsSterilityNationwide
DrugCLASS IIPerrigo Neomycin and Polymixin B Sulfates recalledAltaire PharmaceuticalsSterilityNationwide
DrugCLASS IIOCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose recalledAltaire PharmaceuticalsSterilityNationwide
DrugCLASS IIWalgreens Sodium Chloride Ophthalmic Solution recalledSodium ChlorideAltaire PharmaceuticalsSterilityNationwide