• By Anni Delfaro
    US Food and Drug Administration
    Comprehensive Ophthalmology, Cornea/External Disease

    Altaire Pharmaceuticals has voluntarily recalled 99 ophthalmic products due to the potential for nonsterility. The eye drops and ointments were manufactured and labeled exclusively for Walgreens, Walmart, CVS, Perrigo and other retail stores.

    The recall is a precautionary response to quality assurance concerns at the manufacturing facility, Altaire noted. No injuries have been reported and all recalled products have passed sterility testing.

    Stores have been advised to return all affected units, and patients should immediately discontinue use of the products.

    UPDATE: In addition to the 23 over-the-counter and prescription products listed below, Altaire has voluntarily recalled 30 ophthalmic products sold at CVS15 sold by OCuSOFT and 31 products sold at various retail stores.

     

    Recalled Walgreens products:

    • Lubricant Eye Drops Moisturizing, 15 mL

    1 lot; NDC: 0363-0185-13

    • Lubricant Eye Drops Moisturizing Twin Pack, 2 x 15 mL

    1 lot; NDC: 0363-0185-49

    • Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment, 3.5 gm

    1 lot; NDC: 0363-7500-50              

    • Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 15 mL

    2 lots; NDC: 0363-0193-13

    • Lubricant Eye Ointment PF Soothing, 3.5 gm

    1 lot; NDC: 0363-0191-50

    Recalled Walmart products:

    • Equate Restore Tears Lubricant Eye Drops Twin Pack, 2 x 15 mL

    4 lots; NDC: 49035-189-49

    • Equate Eye Allergy Relief Drops, 15 mL

    15 lots; NDC: 49035-887-13

    • Equate Sterile Lubricant Stye Ointment, 3.5 gm

    8 lots; NDC: 49035-875-50

    • Equate Comfort Gel Lubricant Eye Gel Twin Pack, 2 x 15 mL

    6 lots; NDC: 49035-197-49

    • Equate Restore PM Nighttime Lubricant Eye Ointment, 3.5 gm

    18 lots; NDC: 49035-191-50

    • Equate Night & Day Restore Tears Lubricant Eye Pack, 3.5g and 15mL

    4 lots; NDC: 49035-883-59

    • Equate Support Advanced Twin Pack, 2 x 15 mL

    2 lots; NDC: 49035-885-49

    • Equate Support Advanced Lubricating Eye Drops Dose Preservative Free, 25 count (0.6 mL fill)

    7 lots; NDC: 49035-882-54

    • Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL

    4 lots; NDC: 49035-882-52

    • Equate Support Moisture Lubricant Eye Drops, 10 mL

    5 lots; NDC: 49035-145-10

    • Support Harmony Lubricant Eye Drops, 10 mL

    1 lot; NDC: 49035-145-10

    Recalled Perrigo products:

    • Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment, 3.5 gm

    2 lots; NDC: 0574-4250-35

    • NEO-POLY DEX (Neomycin, Polymixin B and Dexamethasone) Ophthalmic Ointment, 3.5 gm

    28 lots; NDC: 0574-4160-35

    • NEO-POLYCIN HC (Neomycin, Polymixin B, Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment, 3.5 gm

    4 lots; NDC: 0574-4144-35

    • POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment, 3.5 gm

    12 lots; NDC: 0574-4021-35

    • Bacitracin Ophthalmic Ointment, 3.5 gm

    11 lots; NDC: 0574-4022-35

    • Sulfacetamide Sodium Ophthalmic Ointment, 3.5 gm

    2 lots; NDC: 0574-4190-35

    • Puralube Ophthalmic Ointment, 1-3.5 gm

    11 lots; NDC 0574-4025-35 and 0574-4025-20


    Questions regarding this warning should be directed to Altaire Pharmaceuticals Inc. at 1-800-258-2471 or by email at otcdruggist@aol.com from 8:30 a.m. to 5 p.m. ET, Monday through Friday. To date, the FDA is not aware of any reports of illness associated with the use of the recalled products.

    Physicians and patients can report adverse reactions or quality issues to the FDA's MedWatch Adverse Event Reporting program: