Unrated Drug recall · FDA · Published June 29, 2022

Mckesson Medical-Surgical recalls Zaditor eye drops due to improper storage

Mckesson Medical-Surgical recalls Systane Zaditor eye drops (0.035% ketotifen fumarate) because they were stored outside label specifications. This may affect product safety.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1317-2022Drug Mckesson Medical-Surgical ›

Recall notice

CGMP Deviations: products were stored outside the drug label specifications.

Take action

Contact the company

Recalling firmMckesson Medical-Surgical Inc. Corporate Office9954 Maryland Drive, Deep Run Iii Ste. 4000 · Richmond, VA 23233

✎ GovInfoNow plain-language explainer

Mckesson Medical-Surgical is recalling Systane Zaditor eye drops that were stored outside the required drug label specifications. This could lead to improper product safety. Read more at govinfonow.com/recall/34476-mckesson-medical-surgical-recalls-zaditor-eye-drops-due-to-improper.

Source Summary by GovInfoNow · govinfonow.com/recall/34476-mckesson-medical-surgical-recalls-zaditor-eye-drops-due-to-improper · Updated August 18, 2026 · FDA enforcement record: FDA #D-1317-2022

Cite this page

“Mckesson Medical-Surgical recalls Zaditor eye drops due to improper storage.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34476-mckesson-medical-surgical-recalls-zaditor-eye-drops-due-to-improper. Based on FDA recall #D-1317-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1317-2022%22&limit=1).

The FDA announced on June 29, 2022, that Mckesson Medical-Surgical Inc. Corporate Office voluntarily recalled Systane Zaditor ketotifen fumarate ophthalmic solution due to CGMP deviations where products were stored outside label specifications. The recall affects up to 12 units distributed nationwide.

How to tell if you have it

Brand: Mckesson Medical-Surgical
Product: Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box
Manufacturer: Alcon
NDC: 0065-4011-05
Part#: 0065401105
Quantity: up to 12 units

The hazard

According to the FDA, the hazard involves CGMP deviations because the products were stored outside the drug label specifications. The recall status is terminated.

Context

GovInfoNow's records show Mckesson Medical-Surgical Inc. Corporate Office has 14 other recalls on record since June 2, 2021. Other recent recalls include a Clearview Strep A Exact II Dipstick Respiratory Kit recall dated July 30, 2025, and a Medroxyprogesterone Acetate Injectable Vial recall dated April 25, 2025. Additional similar product recalls involve McKesson Gemcitabine Injection on June 10, 2026, and Thea Pharma Similasan Eye Drops along with Thea Pharma iVIZIA Eye Drops, both reported on April 23, 2026.

How to tell if you have this one

Check for the product name 'Systane Zaditor' or 'Ketotifen fumarate ophthalmic solution 0.035%'. The NDC code 0065-4011-05 is also listed on the bottle.

Brand
Mckesson Medical-Surgical
Category
Drug

FDA recall event · 17 products

All 17 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide in the USA.

Recall number	Product, codes & lots	Quantity	NDC
D-1311-2022	Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.; Part# 231209G	6 boxes	—
D-1312-2022	Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.; Part# 444-01-HST	45 boxes	57896-443-66, 57896-443-12, 57896-443-55, 57896-443-05, 57896-443-01
D-1313-2022	Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.; Part# 0065008515	12 boxes	0065-0085-15, 0065-0085-38, 0065-0085-42, 0065-0085-52, 0065008515
D-1314-2022	Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.; Part# a) 0065042915, b) 0065042930	47 bottles	0065-0429-15, 0065-0429-21, 0065-0429-30, 0065-0429-36, 0065-0429-67, 0065042915, 0065042930
D-1315-2022	Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.; Part# 0065053004	16 boxes	—
D-1316-2022	Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.; Part# 0065143302	12 boxes	0065-1433-02, 0065-1433-07, 0065-1433-11, 0065143302
D-1317-2022	Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.; Part# 0065401105	9 boxes	0065-4011-05, 0065-4011-06, 0065-4011-11, 0065401105
D-1318-2022	Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.; Part# 04203710478	131 boxes	63029-321-01, 63029-321-02, 0420371047
D-1319-2022	Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.; Part# 11523723404	67 bottles	11523-7268-3, 11523-7268-8, 11523-7268-7, 11523-7268-4, 11523-7268-9, 11523-7268-5, 11523-7234-1, 11523-7234-2, 11523-7234-3, 11523-7234-4, 11523-7234-5, 11523-7234-6, 11523-7234-9, 11523-7341-1, 11523-7341-2, 11523-4357-1, 11523-4357-3, 11523-4357-5, 11523-4357-2, 1152372340
D-1320-2022	GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.; Part# 30065051801	40 boxes	0065-0518-01, 3006505180
D-1321-2022	Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.; Part# 00065815001	1 box	0065-8150-01, 0065-8150-03, 0065-8150-04, 0065-8150-07, 0006581500
D-1322-2022	A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.	1 Jar	—
D-1323-2022	Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.	113 bottles	0436-0672-16, 0436-0936-16, 0436-0946-16
D-1324-2022	Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.	1 box	—
D-1325-2022	Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.	23 cartons	0487-5901-99
D-1326-2022	Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.; Part# 1116	10 boxes	67777-121-14, 67777-121-19, 67777-121-20, 67777-121-16, 67777-121-17, 67777-121-18, 67777-121-13, 67777-121-11, 67777-121-12, 67777-121-27, 67777-121-26, 67777-121-21, 67777-121-22, 67777-121-23, 67777-121-24
D-1327-2022	Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued); Part# 1203	—	67777-300-01, 67777-300-02, 67777-120-10

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the NDC code 0065-4011-05 on the bottle label to confirm if the product is recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Jun 29, 2022Firm started the recall
Aug 5, 2022FDA classified it Class II
Aug 17, 2022Published in FDA’s Enforcement Report
Feb 13, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34476-mckesson-medical-surgical-recalls-zaditor-eye-drops-due-to-improper">Mckesson Medical-Surgical recalls Zaditor eye drops due to improper storage (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1317-2022 (June 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1317-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.