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-0445-2020	07-02-2019	11-27-2019	Class II	14091 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 54799-505-01	Lack of Assurance of Sterility	Completed
D-0369-2020	07-02-2019	11-27-2019	Class II	259104 units	Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-885-49	Lack of Assurance of Sterility	Completed
D-0469-2020	07-02-2019	11-27-2019	Class II	24144 units	TRP Blur Relief, 15 mL, NDC 17312-002-11	Lack of Assurance of Sterility	Completed
D-0372-2020	07-02-2019	11-27-2019	Class II	17,613 units	Equate 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 Sterility	Completed
D-0490-2020	07-02-2019	11-27-2019	Class II	N/A	Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7	Lack of Assurance of Sterility	Completed
D-0388-2020	07-02-2019	11-27-2019	Class II	39,744 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0428-2020	07-02-2019	11-27-2019	Class II	2,392 units	iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390- 145-10	Lack of Assurance of Sterility	Completed
D-0383-2020	07-02-2019	11-27-2019	Class II	39072 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0402-2020	07-02-2019	11-27-2019	Class II	159864 units	CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Completed
D-0399-2020	07-02-2019	11-27-2019	Class II	2,042,136 units	Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13	Lack of Assurance of Sterility	Completed
D-0377-2020	07-02-2019	11-27-2019	Class II	101,712 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0373-2020	07-02-2019	11-27-2019	Class II	152,369 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0381-2020	07-02-2019	11-27-2019	Class II	101712 units	CVS Health Dry Eye Relief Lubricant Eye Drops, 1 FL OZ (30 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 02895 Made in the USA	Lack of Assurance of Sterility	Completed
D-0397-2020	07-02-2019	11-27-2019	Class II	N/A	Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15	Lack of Assurance of Sterility	Completed
D-0431-2020	07-02-2019	11-27-2019	Class II	48,973 units	iSolutions 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 59390-147-56	Lack of Assurance of Sterility	Completed
D-0355-2020	07-02-2019	11-27-2019	Class II	261,528 units	Polycin (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 0574-4021-35	Lack of Assurance of Sterility	Completed
D-0430-2020	07-02-2019	11-27-2019	Class II	24 units	iSolutions 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 59390-141-52	Lack of Assurance of Sterility	Completed
D-0455-2020	07-02-2019	11-27-2019	Class II	23974 units	Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-192-05	Lack of Assurance of Sterility	Completed
D-0474-2020	07-02-2019	11-27-2019	Class II	195,864 units	Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20	Lack of Assurance of Sterility	Completed
D-0451-2020	07-02-2019	11-27-2019	Class II	29326 units	OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30	Lack of Assurance of Sterility	Completed
D-0358-2020	07-02-2019	11-27-2019	Class II	195,864 unts	Puralube 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 55427	Lack of Assurance of Sterility	Completed
D-0448-2020	07-02-2019	11-27-2019	Class II	296,314 units	OCuSOFT 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 54799-565-59	Lack of Assurance of Sterility	Completed
D-0438-2020	07-02-2019	11-27-2019	Class II	47 units	ActivEyes 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 59390-146-52	Lack of Assurance of Sterility	Completed
D-0389-2020	07-02-2019	11-27-2019	Class II	77,760 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0429-2020	07-02-2019	11-27-2019	Class II	13,407 units	iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-144-10	Lack of Assurance of Sterility	Completed
D-0391-2020	07-02-2019	11-27-2019	Class II	48,168 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0454-2020	07-02-2019	11-27-2019	Class II	50,304 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0374-2020	07-02-2019	11-27-2019	Class II	365,832 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0413-2020	07-02-2019	11-27-2019	Class II	24,024 units	CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Completed
D-0417-2020	07-02-2019	11-27-2019	Class II	22494 units	ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13	Lack of Assurance of Sterility	Completed
D-0375-2020	07-02-2019	11-27-2019	Class II	100,680 units	CVS 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 #247887	Lack of Assurance of Sterility	Completed
D-0461-2020	07-02-2019	11-27-2019	Class II	49527 units	Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05	Lack of Assurance of Sterility	Completed
D-0432-2020	07-02-2019	11-27-2019	Class II	13,375 units	Nano 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 59390-141-56	Lack of Assurance of Sterility	Completed
D-0446-2020	07-02-2019	11-27-2019	Class II	105609 units	OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05	Lack of Assurance of Sterility	Completed
D-0426-2020	07-02-2019	11-27-2019	Class II	202266 units	Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-182-13	Lack of Assurance of Sterility	Completed
D-0354-2020	07-02-2019	11-27-2019	Class II	87922 containers	Perrigo 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 0574-4144-35	Lack of Assurance of Sterility	Completed
D-0466-2020	07-02-2019	11-27-2019	Class II	61830 units	Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 68770-130-15	Lack of Assurance of Sterility	Completed
D-0487-2020	07-02-2019	11-27-2019	Class II	N/A	Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6	Lack of Assurance of Sterility	Completed
D-0419-2020	07-02-2019	11-27-2019	Class II	3060 units	Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire Pharmaceuticals, Inc Aquebogue, NY 11931 NDC 59390-217-02	Lack of Assurance of Sterility	Completed
D-0395-2020	07-02-2019	11-27-2019	Class II	N/A	CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Completed
D-0486-2020	07-02-2019	11-27-2019	Class II	N/A	Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g	Lack of Assurance of Sterility	Completed
D-0366-2020	07-02-2019	11-27-2019	Class II	469128 units	Equate 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 49035-197-49	Lack of Assurance of Sterility	Completed
D-0379-2020	07-02-2019	11-27-2019	Class II	114,504 units	CVS 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 3	Lack of Assurance of Sterility	Completed
D-0464-2020	07-02-2019	11-27-2019	Class II	84216 units	Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15	Lack of Assurance of Sterility	Completed
D-0483-2020	07-02-2019	11-27-2019	Class II	31070 units	FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15	Lack of Assurance of Sterility	Completed
D-0411-2020	07-02-2019	11-27-2019	Class II	464,424 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0436-2020	07-02-2019	11-27-2019	Class II	102,939 units	Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05	Lack of Assurance of Sterility	Completed
D-0422-2020	07-02-2019	11-27-2019	Class II	532,961 units	Altaire 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 59390-205-05	Lack of Assurance of Sterility	Completed
D-0425-2020	07-02-2019	11-27-2019	Class II	809,600 units	Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-35	Lack of Assurance of Sterility	Completed
D-0447-2020	07-02-2019	11-27-2019	Class II	55,134 units	OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01	Lack of Assurance of Sterility	Completed
D-0468-2020	07-02-2019	11-27-2019	Class II	N/A	TRP/ TARGET up & up intensive relief lubricating eye drop, 10 mL	Lack of Assurance of Sterility	Completed
D-0359-2020	07-02-2019	11-27-2019	Class II	35,896 units	Lubricant 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 #801483	Lack of Assurance of Sterility	Completed
D-0407-2020	07-02-2019	11-27-2019	Class II	66,159 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0423-2020	07-02-2019	11-27-2019	Class II	48,542 units	Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13	Lack of Assurance of Sterility	Completed
D-0396-2020	07-02-2019	11-27-2019	Class II	222096 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0440-2020	07-02-2019	11-27-2019	Class II	81403 units	OCuSOFT 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 54799-431-05	Lack of Assurance of Sterility	Completed
D-0376-2020	07-02-2019	11-27-2019	Class II	531,936 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0434-2020	07-02-2019	11-27-2019	Class II	4409 units	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	Lack of Assurance of Sterility	Completed
D-0365-2020	07-02-2019	11-27-2019	Class II	441792 units	Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50	Lack of Assurance of Sterility	Completed
D-0456-2020	07-02-2019	11-27-2019	Class II	N/A	CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Completed
D-0442-2020	07-02-2019	11-27-2019	Class II	75996 units	OCuSOFT 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 54799-503-15	Lack of Assurance of Sterility	Completed
D-0443-2020	07-02-2019	11-27-2019	Class II	9518 units	OCuSOFT 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 54799-504-01	Lack of Assurance of Sterility	Completed
D-0416-2020	07-02-2019	11-27-2019	Class II	46345 units	ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%, Manufactured by: Altaire Pharmaceuticals Inc. Aquebogue, NY 11931, NDC 59390-184-50	Lack of Assurance of Sterility	Completed
D-0489-2020	07-02-2019	11-27-2019	Class II	N/A	Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7	Lack of Assurance of Sterility	Completed
D-0427-2020	07-02-2019	11-27-2019	Class II	137 units	iSolutions 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 59390-208-10	Lack of Assurance of Sterility	Completed
D-0467-2020	07-02-2019	11-27-2019	Class II	20666 units	Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15	Lack of Assurance of Sterility	Completed
D-0352-2020	07-02-2019	11-27-2019	Class II	1737549 containers	Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35	Lack of Assurance of Sterility	Completed
D-0415-2020	07-02-2019	11-27-2019	Class II	306,479 units	Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13	Lack of Assurance of Sterility	Completed
D-0361-2020	07-02-2019	11-27-2019	Class II	30240 units	Walgreens 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 0363-7500-50	Lack of Assurance of Sterility	Completed
D-0387-2020	07-02-2019	11-27-2019	Class II	238,968 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0435-2020	07-02-2019	11-27-2019	Class II	12,716 units	iSolutions 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 59390-143-10	Lack of Assurance of Sterility	Completed
D-0463-2020	07-02-2019	11-27-2019	Class II	41925 units	Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15	Lack of Assurance of Sterility	Completed
D-0420-2020	07-02-2019	11-27-2019	Class II	636 units	Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10	Lack of Assurance of Sterility	Completed
D-0450-2020	07-02-2019	11-27-2019	Class II	81217 units	OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15	Lack of Assurance of Sterility	Completed
D-0357-2020	07-02-2019	11-27-2019	Class II	41148 units	Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4190-35	Lack of Assurance of Sterility	Completed
D-0472-2020	07-02-2019	11-27-2019	Class II	N/A	Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51	Lack of Assurance of Sterility	Completed
D-0459-2020	07-02-2019	11-27-2019	Class II	73,548 units	Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707	Lack of Assurance of Sterility	Completed
D-0401-2020	07-02-2019	11-27-2019	Class II	N/A	CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Completed
D-0405-2020	07-02-2019	11-27-2019	Class II	58,704 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0392-2020	07-02-2019	11-27-2019	Class II	483528 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0404-2020	07-02-2019	11-27-2019	Class II	48,168 units	CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Completed
D-0385-2020	07-02-2019	11-27-2019	Class II	N/A	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0380-2020	07-02-2019	11-27-2019	Class II	39,288 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0478-2020	07-02-2019	11-27-2019	Class II	6024 units	Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05	Lack of Assurance of Sterility	Completed
D-0370-2020	07-02-2019	11-27-2019	Class II	99420 units	Equate 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 49035-882-54	Lack of Assurance of Sterility	Completed
D-0421-2020	07-02-2019	11-27-2019	Class II	390 units	Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-02	Lack of Assurance of Sterility	Completed
D-0414-2020	07-02-2019	11-27-2019	Class II	6,877 units	iSolutions 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 59390-190-50	Lack of Assurance of Sterility	Completed
D-0441-2020	07-02-2019	11-27-2019	Class II	88,008 units	Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15	Lack of Assurance of Sterility	Completed
D-0458-2020	07-02-2019	11-27-2019	Class II	90072 units	Accutome 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 63448-411-04	Lack of Assurance of Sterility	Completed
D-0433-2020	07-02-2019	11-27-2019	Class II	1,666 units	Nano 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 59390-142-49	Lack of Assurance of Sterility	Completed
D-0481-2020	07-02-2019	11-27-2019	Class II	19632 units	OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76	Lack of Assurance of Sterility	Completed
D-0386-2020	07-02-2019	11-27-2019	Class II	159,864 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0403-2020	07-02-2019	11-27-2019	Class II	39,744 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0353-2020	07-02-2019	11-27-2019	Class II	121572 containers	Perrigo 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 0574-4250-35	Lack of Assurance of Sterility	Completed
D-0356-2020	07-02-2019	11-27-2019	Class II	651528 units	Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35	Lack of Assurance of Sterility	Completed
D-0449-2020	07-02-2019	11-27-2019	Class II	427,280 units	OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21	Lack of Assurance of Sterility	Completed
D-0394-2020	07-02-2019	11-27-2019	Class II	N/A	CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Completed
D-0418-2020	07-02-2019	11-27-2019	Class II	161077 units	ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50	Lack of Assurance of Sterility	Completed
D-0470-2020	07-02-2019	11-27-2019	Class II	318,412 units	TRP Stye Relief, 4 g, NDC 17312-014-13	Lack of Assurance of Sterility	Completed
D-0384-2020	07-02-2019	11-27-2019	Class II	284,232 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0367-2020	07-02-2019	11-27-2019	Class II	1537130 units	Equate 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 49035-191-50	Lack of Assurance of Sterility	Completed
D-0390-2020	07-02-2019	11-27-2019	Class II	109,020 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0471-2020	07-02-2019	11-27-2019	Class II	1,381,638 units	TRP Pink Eye Relief, 10 mL, NDC 17312-013-15	Lack of Assurance of Sterility	Completed
D-0363-2020	07-02-2019	11-27-2019	Class II	45672 units	Walgreen'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 0363-0191-50	Lack of Assurance of Sterility	Completed
D-0368-2020	07-02-2019	11-27-2019	Class II	55772 units	Equate 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 49035-883-59	Lack of Assurance of Sterility	Completed
D-0452-2020	07-02-2019	11-27-2019	Class II	19632 units	OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA	Lack of Assurance of Sterility	Completed
D-0437-2020	07-02-2019	11-27-2019	Class II	88 units	ActivEyes 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 59390-148-52	Lack of Assurance of Sterility	Completed
D-0360-2020	07-02-2019	11-27-2019	Class II	N/A	Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package Size: 2 x 15 mL, NDC 0363-0185-49	Lack of Assurance of Sterility	Completed
D-0439-2020	07-02-2019	11-27-2019	Class II	48 units	ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931,NDC 59390-189-50	Lack of Assurance of Sterility	Completed
D-0398-2020	07-02-2019	11-27-2019	Class II	139572 units	Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15	Lack of Assurance of Sterility	Completed
D-0477-2020	07-02-2019	11-27-2019	Class II	N/A	CVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Completed
D-0465-2020	07-02-2019	11-27-2019	Class II	41906 units	Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-104-15	Lack of Assurance of Sterility	Completed
D-0424-2020	07-02-2019	11-27-2019	Class II	414,346 units	Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-18	Lack of Assurance of Sterility	Completed
D-0485-2020	07-02-2019	11-27-2019	Class II	73548 units	Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL	Lack of Assurance of Sterility	Completed
D-0406-2020	07-02-2019	11-27-2019	Class II	39,072 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0479-2020	07-02-2019	11-27-2019	Class II	2870 units	Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51	Lack of Assurance of Sterility	Completed
D-0476-2020	07-02-2019	11-27-2019	Class II	114504 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0393-2020	07-02-2019	11-27-2019	Class II	464424 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0453-2020	07-02-2019	11-27-2019	Class II	13626 units	OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA	Lack of Assurance of Sterility	Completed
D-0378-2020	07-02-2019	11-27-2019	Class II	45,864 units	CVS 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 6	Lack of Assurance of Sterility	Completed
D-0382-2020	07-02-2019	11-27-2019	Class II	45864 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0410-2020	07-02-2019	11-27-2019	Class II	483,528 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0412-2020	07-02-2019	11-27-2019	Class II	222,096 units	CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Completed
D-0473-2020	07-02-2019	11-27-2019	Class II	273,100 units	Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35	Lack of Assurance of Sterility	Completed
D-0371-2020	07-02-2019	11-27-2019	Class II	50,904 units	Equate 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 49035-882-54	Lack of Assurance of Sterility	Completed
D-0482-2020	07-02-2019	11-27-2019	Class II	N/A	OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77	Lack of Assurance of Sterility	Completed
D-0462-2020	07-02-2019	11-27-2019	Class II	81969 units	Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15	Lack of Assurance of Sterility	Completed
D-0409-2020	07-02-2019	11-27-2019	Class II	37656 units	CVS 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 02895	Lack of Assurance of Sterility	Completed
D-0364-2020	07-02-2019	11-27-2019	Class II	557,376 units	Equate 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 49035-189-49	Lack of Assurance of Sterility	Completed
D-0444-2020	07-02-2019	11-27-2019	Class II	103856 units	OCuSOFT 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 54799-504-05	Lack of Assurance of Sterility	Completed
D-0457-2020	07-02-2019	11-27-2019	Class II	90,072 units	Accutome 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 63448-411-04	Lack of Assurance of Sterility	Completed
D-0480-2020	07-02-2019	11-27-2019	Class II	N/A	Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-143-51	Lack of Assurance of Sterility	Completed
D-0362-2020	07-02-2019	11-27-2019	Class II	43008 units	Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road Deerfield IL 60015 NDC 0363-0193-13	Lack of Assurance of Sterility	Completed
D-0475-2020	07-02-2019	11-27-2019	Class II	N/A	Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52	Lack of Assurance of Sterility	Completed

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0363-7500	Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	Sodium Chloride	Ointment	Ophthalmic	Walgreen Company	Human Otc Drug
0574-4021	Polycin	Bacitracin Zinc And Polymyxin B Sulfates	Ointment	Ophthalmic	Padagis Us Llc	Human Prescription Drug
0574-4022	Bacitracin	Bacitracin	Ointment	Ophthalmic	Padagis Us Llc	Human Prescription Drug
0574-4144	Neo Polycin Hc	Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone Acetate	Ointment	Ophthalmic	Padagis Us Llc	Human Prescription Drug
0574-4160	Neomycin And Polymyxin B Sulfates And Dexamethasone	Neomycin, Polymyxin B Sulfates, Dexamethasone	Ointment	Ophthalmic	Padagis Us Llc	Human Prescription Drug
0574-4190	Sulfacetamide Sodium	Sulfacetamide Sodium	Ointment	Ophthalmic	Padagis Us Llc	Human Prescription Drug
0574-4250	Neo Polycin	Neomycin And Polymyxin B Sulfates And Bacitracin Zinc	Ointment	Ophthalmic	Padagis Us Llc	Human Prescription Drug
59390-140	Ofloxacin Ophthalmic	Ofloxacin	Solution	Ophthalmic	Altaire Pharmaceuticals Inc.	Human Prescription Drug
59390-149	Diclofenac	Diclofenac Sodium	Solution/ Drops	Ophthalmic	Altaire Pharmaceuticals Inc.	Human Prescription Drug
59390-182	Goniotaire	Hypromellose 2906 (4000 Mpa.s)	Solution	Ophthalmic	Altaire Pharmaceuticals Inc.	Human Prescription Drug
59390-183	Altachlore Sodium Chloride Hypertonicity	Sodium Chloride	Solution/ Drops	Ophthalmic	Altaire Pharmaceuticals Inc.	Human Otc Drug
59390-192	Homatropine Hydrobromide Ophthalmic	Homatropine Hydrobromide	Solution	Ophthalmic	Altaire Pharmaceuticals Inc.	Human Prescription Drug
59390-198	Altalube	Mineral Oil And Petrolatum	Ointment	Ophthalmic	Altaire Pharmaceuticals Inc.	Human Otc Drug
59390-205	Fluorescein Sodium And Proparacaine Hydrochloride	Fluorescein Sodium And Proparacaine Hydrochloride	Solution/ Drops	Ophthalmic	Altaire Pharmaceuticals Inc.	Human Prescription Drug
59390-217	Ciprofloxacin Hcl Ophthalmic	Ciprofloxacin Hydrochloride	Solution	Ophthalmic	Altaire Pharmaceuticals Inc.	Human Prescription Drug