Drug recall: Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manuf
FDA enforcement event 83265 is a drug recall by Altaire Pharmaceuticals, Inc. of Aquebogue, NY, initiated 2 Jul 2019 and classified Class II, with 134 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Altaire Pharmaceuticals, Inc. has 2 enforcement events on this register, with a median of 134 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Altaire Pharmaceuticals, Inc., Aquebogue, NY.
Reason for recall
"Lack of Assurance of Sterility"
Distribution
"U.S.A. Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0352-2020 | 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 | 1737549 containers | Class II | Completed | 27 Nov 2019 |
| D-0353-2020 | 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 | 121572 containers | Class II | Completed | 27 Nov 2019 |
| D-0354-2020 | 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 | 87922 containers | Class II | Completed | 27 Nov 2019 |
| D-0355-2020 | 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 | 261,528 units | Class II | Completed | 27 Nov 2019 |
| D-0356-2020 | Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35 | 651528 units | Class II | Completed | 27 Nov 2019 |
| D-0357-2020 | 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 | 41148 units | Class II | Completed | 27 Nov 2019 |
| D-0358-2020 | 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 | 195,864 unts | Class II | Completed | 27 Nov 2019 |
| D-0359-2020 | 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 | 35,896 units | Class II | Completed | 27 Nov 2019 |
| D-0360-2020 | Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package Size: 2 x 15 mL, NDC 0363-0185-49 | N/A | Class II | Completed | 27 Nov 2019 |
| D-0361-2020 | 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 | 30240 units | Class II | Completed | 27 Nov 2019 |
| D-0362-2020 | 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 | 43008 units | Class II | Completed | 27 Nov 2019 |
| D-0363-2020 | 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 | 45672 units | Class II | Completed | 27 Nov 2019 |
| D-0364-2020 | 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 | 557,376 units | Class II | Completed | 27 Nov 2019 |
| D-0365-2020 | 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 | 441792 units | Class II | Completed | 27 Nov 2019 |
| D-0366-2020 | 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 | 469128 units | Class II | Completed | 27 Nov 2019 |
| D-0367-2020 | 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 | 1537130 units | Class II | Completed | 27 Nov 2019 |
| D-0368-2020 | 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 | 55772 units | Class II | Completed | 27 Nov 2019 |
| D-0369-2020 | 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 | 259104 units | Class II | Completed | 27 Nov 2019 |
| D-0370-2020 | 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 | 99420 units | Class II | Completed | 27 Nov 2019 |
| D-0371-2020 | 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 | 50,904 units | Class II | Completed | 27 Nov 2019 |
| D-0372-2020 | 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.) | 17,613 units | Class II | Completed | 27 Nov 2019 |
| D-0373-2020 | 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 | 152,369 units | Class II | Completed | 27 Nov 2019 |
| D-0374-2020 | 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 | 365,832 units | Class II | Completed | 27 Nov 2019 |
| D-0375-2020 | 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 | 100,680 units | Class II | Completed | 27 Nov 2019 |
| D-0376-2020 | 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 | 531,936 units | Class II | Completed | 27 Nov 2019 |
| D-0377-2020 | 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 | 101,712 units | Class II | Completed | 27 Nov 2019 |
| D-0378-2020 | 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 | 45,864 units | Class II | Completed | 27 Nov 2019 |
| D-0379-2020 | 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 | 114,504 units | Class II | Completed | 27 Nov 2019 |
| D-0380-2020 | 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 | 39,288 units | Class II | Completed | 27 Nov 2019 |
| D-0381-2020 | 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 | 101712 units | Class II | Completed | 27 Nov 2019 |
| D-0382-2020 | 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 | 45864 units | Class II | Completed | 27 Nov 2019 |
| D-0383-2020 | 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 | 39072 units | Class II | Completed | 27 Nov 2019 |
| D-0384-2020 | 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 | 284,232 units | Class II | Completed | 27 Nov 2019 |
| D-0385-2020 | 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 | N/A | Class II | Completed | 27 Nov 2019 |
| D-0386-2020 | 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 | 159,864 units | Class II | Completed | 27 Nov 2019 |
| D-0387-2020 | 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 | 238,968 units | Class II | Completed | 27 Nov 2019 |
| D-0388-2020 | 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 | 39,744 units | Class II | Completed | 27 Nov 2019 |
| D-0389-2020 | 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 | 77,760 units | Class II | Completed | 27 Nov 2019 |
| D-0390-2020 | 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 | 109,020 units | Class II | Completed | 27 Nov 2019 |
| D-0391-2020 | 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 | 48,168 units | Class II | Completed | 27 Nov 2019 |
| D-0392-2020 | 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 | 483528 units | Class II | Completed | 27 Nov 2019 |
| D-0393-2020 | 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 | 464424 units | Class II | Completed | 27 Nov 2019 |
| D-0394-2020 | 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 | N/A | Class II | Completed | 27 Nov 2019 |
| D-0395-2020 | CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | N/A | Class II | Completed | 27 Nov 2019 |
| D-0396-2020 | 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 | 222096 units | Class II | Completed | 27 Nov 2019 |
| D-0397-2020 | Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15 | N/A | Class II | Completed | 27 Nov 2019 |
| D-0398-2020 | Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15 | 139572 units | Class II | Completed | 27 Nov 2019 |
| D-0399-2020 | 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 | 2,042,136 units | Class II | Completed | 27 Nov 2019 |
| D-0401-2020 | CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | N/A | Class II | Completed | 27 Nov 2019 |
| D-0402-2020 | 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 | 159864 units | Class II | Completed | 27 Nov 2019 |
| D-0403-2020 | 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 | 39,744 units | Class II | Completed | 27 Nov 2019 |
| D-0404-2020 | CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | 48,168 units | Class II | Completed | 27 Nov 2019 |
| D-0405-2020 | 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 | 58,704 units | Class II | Completed | 27 Nov 2019 |
| D-0406-2020 | 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 | 39,072 units | Class II | Completed | 27 Nov 2019 |
| D-0407-2020 | 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 | 66,159 units | Class II | Completed | 27 Nov 2019 |
| D-0409-2020 | 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 | 37656 units | Class II | Completed | 27 Nov 2019 |
| D-0410-2020 | 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 | 483,528 units | Class II | Completed | 27 Nov 2019 |
| D-0411-2020 | 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 | 464,424 units | Class II | Completed | 27 Nov 2019 |
| D-0412-2020 | CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | 222,096 units | Class II | Completed | 27 Nov 2019 |
| D-0413-2020 | CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | 24,024 units | Class II | Completed | 27 Nov 2019 |
Showing 60 of 134 product records; the FDA enforcement report lists all of them.
Context
68%of 2019 drug events are Class II362 events that year
134product records in this eventfirm median: 134
2events on this register for the firm
Other enforcement events for Altaire Pharmaceuticals, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Sep 2013 | Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS (66217) | Drug | Class I | 1 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.A. Nationwide"
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.