Recall Enforment Report D-0445-2020

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Altaire Pharmaceuticals, Inc., originally initiated on 07-02-2019 for the product OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently completed.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0445-202007-02-201911-27-2019Class II14091 cartons.OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01Lack of Assurance of SterilityCompleted
D-0369-202007-02-201911-27-2019Class II259104 unitsEquate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-885-49Lack of Assurance of SterilityCompleted
D-0469-202007-02-201911-27-2019Class II24144 unitsTRP Blur Relief, 15 mL, NDC 17312-002-11Lack of Assurance of SterilityCompleted
D-0372-202007-02-201911-27-2019Class II17,613 unitsEquate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-145-10 (Note: Support Harmony packaging was discontinued in January 2018.)Lack of Assurance of SterilityCompleted
D-0490-202007-02-201911-27-2019Class IIN/AClear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7Lack of Assurance of SterilityCompleted
D-0388-202007-02-201911-27-2019Class II39,744 unitsCVS Health Preservative Free Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item #994881 Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0428-202007-02-201911-27-2019Class II2,392 unitsiSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390- 145-10Lack of Assurance of SterilityCompleted
D-0383-202007-02-201911-27-2019Class II39072 unitsCVS Health Preservative Free Lubricant Eye Drops, 60 Sterile Single-Use Containers, 0.02 FL OZ (0.6 mL) EACH, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0402-202007-02-201911-27-2019Class II159864 unitsCVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0399-202007-02-201911-27-2019Class II2,042,136 unitsEquate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13Lack of Assurance of SterilityCompleted
D-0377-202007-02-201911-27-2019Class II101,712 unitsCVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0373-202007-02-201911-27-2019Class II152,369 unitsCVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0381-202007-02-201911-27-2019Class II101712 unitsCVS Health Dry Eye Relief Lubricant Eye Drops, 1 FL OZ (30 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 02895 Made in the USALack of Assurance of SterilityCompleted
D-0397-202007-02-201911-27-2019Class IIN/AOcusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15Lack of Assurance of SterilityCompleted
D-0431-202007-02-201911-27-2019Class II48,973 unitsiSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-147-56Lack of Assurance of SterilityCompleted
D-0355-202007-02-201911-27-2019Class II261,528 unitsPolycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35Lack of Assurance of SterilityCompleted
D-0430-202007-02-201911-27-2019Class II24 unitsiSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-52Lack of Assurance of SterilityCompleted
D-0455-202007-02-201911-27-2019Class II23974 unitsAltaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-192-05Lack of Assurance of SterilityCompleted
D-0474-202007-02-201911-27-2019Class II195,864 unitsPuralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20Lack of Assurance of SterilityCompleted
D-0451-202007-02-201911-27-2019Class II29326 unitsOCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30Lack of Assurance of SterilityCompleted
D-0358-202007-02-201911-27-2019Class II195,864 untsPuralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (NDC 0574-4025-35), Manufactured for Perrigo, Minneapolis, MN 55427Lack of Assurance of SterilityCompleted
D-0448-202007-02-201911-27-2019Class II296,314 unitsOCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59Lack of Assurance of SterilityCompleted
D-0438-202007-02-201911-27-2019Class II47 unitsActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-146-52Lack of Assurance of SterilityCompleted
D-0389-202007-02-201911-27-2019Class II77,760 unitsCVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0429-202007-02-201911-27-2019Class II13,407 unitsiSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-144-10Lack of Assurance of SterilityCompleted
D-0391-202007-02-201911-27-2019Class II48,168 unitsCVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5% Glycerin 1% Polysorbate 80 0.5%), Advanced Relief, 30 Sterile Single-Use Containers 0.02 fl. oz. (0.6 mL) each, Item #563442, NDC 50428 30295 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0454-202007-02-201911-27-2019Class II50,304 unitsCVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0374-202007-02-201911-27-2019Class II365,832 unitsCVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0413-202007-02-201911-27-2019Class II24,024 unitsCVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0417-202007-02-201911-27-2019Class II22494 unitsActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13Lack of Assurance of SterilityCompleted
D-0375-202007-02-201911-27-2019Class II100,680 unitsCVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Item #247887Lack of Assurance of SterilityCompleted
D-0461-202007-02-201911-27-2019Class II49527 unitsAltaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05Lack of Assurance of SterilityCompleted
D-0432-202007-02-201911-27-2019Class II13,375 unitsNano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-56Lack of Assurance of SterilityCompleted
D-0446-202007-02-201911-27-2019Class II105609 unitsOCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05Lack of Assurance of SterilityCompleted
D-0426-202007-02-201911-27-2019Class II202266 unitsAltaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-182-13Lack of Assurance of SterilityCompleted
D-0354-202007-02-201911-27-2019Class II87922 containersPerrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz), Rx only, Mfd. For Perrigo Minneapolis, MN 55427, NDC 0574-4144-35Lack of Assurance of SterilityCompleted
D-0466-202007-02-201911-27-2019Class II61830 unitsNatural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 68770-130-15Lack of Assurance of SterilityCompleted
D-0487-202007-02-201911-27-2019Class IIN/AClear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6Lack of Assurance of SterilityCompleted
D-0419-202007-02-201911-27-2019Class II3060 unitsAltaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire Pharmaceuticals, Inc Aquebogue, NY 11931 NDC 59390-217-02Lack of Assurance of SterilityCompleted
D-0395-202007-02-201911-27-2019Class IIN/ACVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0486-202007-02-201911-27-2019Class IIN/AGrandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 gLack of Assurance of SterilityCompleted
D-0366-202007-02-201911-27-2019Class II469128 unitsEquate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49Lack of Assurance of SterilityCompleted
D-0379-202007-02-201911-27-2019Class II114,504 unitsCVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39945 3Lack of Assurance of SterilityCompleted
D-0464-202007-02-201911-27-2019Class II84216 unitsNatural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15Lack of Assurance of SterilityCompleted
D-0483-202007-02-201911-27-2019Class II31070 unitsFreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15Lack of Assurance of SterilityCompleted
D-0411-202007-02-201911-27-2019Class II464,424 unitsCVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0436-202007-02-201911-27-2019Class II102,939 unitsOfloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05Lack of Assurance of SterilityCompleted
D-0422-202007-02-201911-27-2019Class II532,961 unitsAltaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-205-05Lack of Assurance of SterilityCompleted
D-0425-202007-02-201911-27-2019Class II809,600 unitsAltaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-35Lack of Assurance of SterilityCompleted
D-0447-202007-02-201911-27-2019Class II55,134 unitsOCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01Lack of Assurance of SterilityCompleted
D-0468-202007-02-201911-27-2019Class IIN/ATRP/ TARGET up & up intensive relief lubricating eye drop, 10 mLLack of Assurance of SterilityCompleted
D-0359-202007-02-201911-27-2019Class II35,896 unitsLubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL), Distributed by: Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, Item #801483Lack of Assurance of SterilityCompleted
D-0407-202007-02-201911-27-2019Class II66,159 unitsCVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz. (10 mL), Item #968210, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0423-202007-02-201911-27-2019Class II48,542 unitsAltaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13Lack of Assurance of SterilityCompleted
D-0396-202007-02-201911-27-2019Class II222096 unitsCVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0440-202007-02-201911-27-2019Class II81403 unitsOCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05Lack of Assurance of SterilityCompleted
D-0376-202007-02-201911-27-2019Class II531,936 unitsCVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0434-202007-02-201911-27-2019Class II4409 unitsiSolutions 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 59390-142-13Lack of Assurance of SterilityCompleted
D-0365-202007-02-201911-27-2019Class II441792 unitsEquate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50Lack of Assurance of SterilityCompleted
D-0456-202007-02-201911-27-2019Class IIN/ACVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0442-202007-02-201911-27-2019Class II75996 unitsOCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15Lack of Assurance of SterilityCompleted
D-0443-202007-02-201911-27-2019Class II9518 unitsOCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01Lack of Assurance of SterilityCompleted
D-0416-202007-02-201911-27-2019Class II46345 unitsActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%, Manufactured by: Altaire Pharmaceuticals Inc. Aquebogue, NY 11931, NDC 59390-184-50Lack of Assurance of SterilityCompleted
D-0489-202007-02-201911-27-2019Class IIN/AClear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7Lack of Assurance of SterilityCompleted
D-0427-202007-02-201911-27-2019Class II137 unitsiSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL), Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-208-10Lack of Assurance of SterilityCompleted
D-0467-202007-02-201911-27-2019Class II20666 unitsNatural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15Lack of Assurance of SterilityCompleted
D-0352-202007-02-201911-27-2019Class II1737549 containersPerrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35Lack of Assurance of SterilityCompleted
D-0415-202007-02-201911-27-2019Class II306,479 unitsAltacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13Lack of Assurance of SterilityCompleted
D-0361-202007-02-201911-27-2019Class II30240 unitsWalgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile, Net Wt. 0.125 oz (3.5 g), Distributed by Walgreen Co. 200 Wilmot Road Deerfield, IL 60015, NDC 0363-7500-50Lack of Assurance of SterilityCompleted
D-0387-202007-02-201911-27-2019Class II238,968 unitsCVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0435-202007-02-201911-27-2019Class II12,716 unitsiSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10Lack of Assurance of SterilityCompleted
D-0463-202007-02-201911-27-2019Class II41925 unitsNatural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15Lack of Assurance of SterilityCompleted
D-0420-202007-02-201911-27-2019Class II636 unitsAltaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10Lack of Assurance of SterilityCompleted
D-0450-202007-02-201911-27-2019Class II81217 unitsOCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15Lack of Assurance of SterilityCompleted
D-0357-202007-02-201911-27-2019Class II41148 unitsPerrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4190-35Lack of Assurance of SterilityCompleted
D-0472-202007-02-201911-27-2019Class IIN/ANano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51Lack of Assurance of SterilityCompleted
D-0459-202007-02-201911-27-2019Class II73,548 unitsGrandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707Lack of Assurance of SterilityCompleted
D-0401-202007-02-201911-27-2019Class IIN/ACVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0405-202007-02-201911-27-2019Class II58,704 unitsCVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0392-202007-02-201911-27-2019Class II483528 unitsCVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0404-202007-02-201911-27-2019Class II48,168 unitsCVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0385-202007-02-201911-27-2019Class IIN/ACVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0380-202007-02-201911-27-2019Class II39,288 unitsCVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 0805 Made in the USA 02895Lack of Assurance of SterilityCompleted
D-0478-202007-02-201911-27-2019Class II6024 unitsAltaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05Lack of Assurance of SterilityCompleted
D-0370-202007-02-201911-27-2019Class II99420 unitsEquate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M item #: 563031654, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54Lack of Assurance of SterilityCompleted
D-0421-202007-02-201911-27-2019Class II390 unitsAltaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-02Lack of Assurance of SterilityCompleted
D-0414-202007-02-201911-27-2019Class II6,877 unitsiSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50Lack of Assurance of SterilityCompleted
D-0441-202007-02-201911-27-2019Class II88,008 unitsTetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15Lack of Assurance of SterilityCompleted
D-0458-202007-02-201911-27-2019Class II90072 unitsAccutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04Lack of Assurance of SterilityCompleted
D-0433-202007-02-201911-27-2019Class II1,666 unitsNano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-49Lack of Assurance of SterilityCompleted
D-0481-202007-02-201911-27-2019Class II19632 unitsOCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76Lack of Assurance of SterilityCompleted
D-0386-202007-02-201911-27-2019Class II159,864 unitsCVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799143, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0403-202007-02-201911-27-2019Class II39,744 unitsCVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0353-202007-02-201911-27-2019Class II121572 containersPerrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Perrigo Minneapolis, MN 55427 NDC 0574-4250-35Lack of Assurance of SterilityCompleted
D-0356-202007-02-201911-27-2019Class II651528 unitsPerrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35Lack of Assurance of SterilityCompleted
D-0449-202007-02-201911-27-2019Class II427,280 unitsOCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21Lack of Assurance of SterilityCompleted
D-0394-202007-02-201911-27-2019Class IIN/ACVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0418-202007-02-201911-27-2019Class II161077 unitsActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50Lack of Assurance of SterilityCompleted
D-0470-202007-02-201911-27-2019Class II318,412 unitsTRP Stye Relief, 4 g, NDC 17312-014-13Lack of Assurance of SterilityCompleted
D-0384-202007-02-201911-27-2019Class II284,232 unitsCVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0367-202007-02-201911-27-2019Class II1537130 unitsEquate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc., Bentonville, AR 72716, W-M item #551282425, NDC 49035-191-50Lack of Assurance of SterilityCompleted
D-0390-202007-02-201911-27-2019Class II109,020 unitsCVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%, Sensitive Solution, 70 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #457791, NDC 50428 41429 3, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0471-202007-02-201911-27-2019Class II1,381,638 unitsTRP Pink Eye Relief, 10 mL, NDC 17312-013-15Lack of Assurance of SterilityCompleted
D-0363-202007-02-201911-27-2019Class II45672 unitsWalgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Item #801486, NDC 0363-0191-50Lack of Assurance of SterilityCompleted
D-0368-202007-02-201911-27-2019Class II55772 unitsEquate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, Package Size: 3.5g and 15mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-883-59Lack of Assurance of SterilityCompleted
D-0452-202007-02-201911-27-2019Class II19632 unitsOCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USALack of Assurance of SterilityCompleted
D-0437-202007-02-201911-27-2019Class II88 unitsActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-148-52Lack of Assurance of SterilityCompleted
D-0360-202007-02-201911-27-2019Class IIN/ALubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package Size: 2 x 15 mL, NDC 0363-0185-49Lack of Assurance of SterilityCompleted
D-0439-202007-02-201911-27-2019Class II48 unitsActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931,NDC 59390-189-50Lack of Assurance of SterilityCompleted
D-0398-202007-02-201911-27-2019Class II139572 unitsOcusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15Lack of Assurance of SterilityCompleted
D-0477-202007-02-201911-27-2019Class IIN/ACVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0465-202007-02-201911-27-2019Class II41906 unitsNatural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-104-15Lack of Assurance of SterilityCompleted
D-0424-202007-02-201911-27-2019Class II414,346 unitsAltaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-18Lack of Assurance of SterilityCompleted
D-0485-202007-02-201911-27-2019Class II73548 unitsGrandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mLLack of Assurance of SterilityCompleted
D-0406-202007-02-201911-27-2019Class II39,072 unitsCVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0479-202007-02-201911-27-2019Class II2870 unitsNano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51Lack of Assurance of SterilityCompleted
D-0476-202007-02-201911-27-2019Class II114504 unitsCVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0393-202007-02-201911-27-2019Class II464424 unitsCVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0453-202007-02-201911-27-2019Class II13626 unitsOCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USALack of Assurance of SterilityCompleted
D-0378-202007-02-201911-27-2019Class II45,864 unitsCVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, Item #495334, 60 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 31010 6Lack of Assurance of SterilityCompleted
D-0382-202007-02-201911-27-2019Class II45864 unitsCVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334,Product Size: 0.6 mL x 60 count, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0410-202007-02-201911-27-2019Class II483,528 unitsCVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz., (15 mL), Item #994880, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0412-202007-02-201911-27-2019Class II222,096 unitsCVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0473-202007-02-201911-27-2019Class II273,100 unitsPuralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35Lack of Assurance of SterilityCompleted
D-0371-202007-02-201911-27-2019Class II50,904 unitsEquate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M Item # 563031654, Package Size 7.5 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54Lack of Assurance of SterilityCompleted
D-0482-202007-02-201911-27-2019Class IIN/AOCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77Lack of Assurance of SterilityCompleted
D-0462-202007-02-201911-27-2019Class II81969 unitsNatural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15Lack of Assurance of SterilityCompleted
D-0409-202007-02-201911-27-2019Class II37656 unitsCVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 495323, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Lack of Assurance of SterilityCompleted
D-0364-202007-02-201911-27-2019Class II557,376 unitsEquate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-189-49Lack of Assurance of SterilityCompleted
D-0444-202007-02-201911-27-2019Class II103856 unitsOCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05Lack of Assurance of SterilityCompleted
D-0457-202007-02-201911-27-2019Class II90,072 unitsAccutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04Lack of Assurance of SterilityCompleted
D-0480-202007-02-201911-27-2019Class IIN/ANano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-143-51Lack of Assurance of SterilityCompleted
D-0362-202007-02-201911-27-2019Class II43008 unitsWalgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road Deerfield IL 60015 NDC 0363-0193-13Lack of Assurance of SterilityCompleted
D-0475-202007-02-201911-27-2019Class IIN/AEquate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52Lack of Assurance of SterilityCompleted

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0363-7500Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye Sodium ChlorideOintmentOphthalmicWalgreen CompanyHuman Otc Drug
0574-4021Polycin Bacitracin Zinc And Polymyxin B SulfatesOintmentOphthalmicPadagis Us LlcHuman Prescription Drug
0574-4022Bacitracin BacitracinOintmentOphthalmicPadagis Us LlcHuman Prescription Drug
0574-4144Neo Polycin Hc Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone AcetateOintmentOphthalmicPadagis Us LlcHuman Prescription Drug
0574-4160Neomycin And Polymyxin B Sulfates And Dexamethasone Neomycin, Polymyxin B Sulfates, DexamethasoneOintmentOphthalmicPadagis Us LlcHuman Prescription Drug
0574-4190Sulfacetamide Sodium Sulfacetamide SodiumOintmentOphthalmicPadagis Us LlcHuman Prescription Drug
0574-4250Neo Polycin Neomycin And Polymyxin B Sulfates And Bacitracin ZincOintmentOphthalmicPadagis Us LlcHuman Prescription Drug
59390-140Ofloxacin Ophthalmic OfloxacinSolutionOphthalmicAltaire Pharmaceuticals Inc.Human Prescription Drug
59390-149Diclofenac Diclofenac SodiumSolution/ DropsOphthalmicAltaire Pharmaceuticals Inc.Human Prescription Drug
59390-182Goniotaire Hypromellose 2906 (4000 Mpa.s)SolutionOphthalmicAltaire Pharmaceuticals Inc.Human Prescription Drug
59390-183Altachlore Sodium Chloride Hypertonicity Sodium ChlorideSolution/ DropsOphthalmicAltaire Pharmaceuticals Inc.Human Otc Drug
59390-192Homatropine Hydrobromide Ophthalmic Homatropine HydrobromideSolutionOphthalmicAltaire Pharmaceuticals Inc.Human Prescription Drug
59390-198Altalube Mineral Oil And PetrolatumOintmentOphthalmicAltaire Pharmaceuticals Inc.Human Otc Drug
59390-205Fluorescein Sodium And Proparacaine Hydrochloride Fluorescein Sodium And Proparacaine HydrochlorideSolution/ DropsOphthalmicAltaire Pharmaceuticals Inc.Human Prescription Drug
59390-217Ciprofloxacin Hcl Ophthalmic Ciprofloxacin HydrochlorideSolutionOphthalmicAltaire Pharmaceuticals Inc.Human Prescription Drug