Medications & Supplements/Over-the-Counter

McKesson Medical-Surgical Medications Recalled for Improper Storage

Agency Publication Date: August 5, 2022

Summary

McKesson Medical-Surgical Inc. is recalling 534 units of various over-the-counter medications and supplies, including Systane eye drops, Miralax (polyethylene glycol 3350), and Dakin's Solution (sodium hypochlorite), because they were stored outside of the temperature and environmental conditions required by their labels. The products were sold nationwide and include brands such as Alcon, Bayer, Nephron, and Dynarex. No incidents or injuries have been reported to date, but the storage error was initiated after a discovery that products were kept in conditions that did not meet Good Manufacturing Practice (CGMP) standards.

Risk

Medications and medical supplies stored outside of their required temperature or humidity ranges may lose their effectiveness or become unstable. This could result in patients receiving a less potent dose than intended or experiencing unexpected reactions.

What You Should Do

This recall affects multiple brands and products including Alcon eye drops (Systane, Pataday, Naphcon A, GenTeal), Bayer products (Miralax, A&D Ointment), Dakin's Solution, Nephron inhalation solutions, and Dynarex alcohol pads.
See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact McKesson Medical-Surgical Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dakin's Solution (473 mL)

Variants: Sodium hypochlorite 0.125% (Quarter Strength), Sodium hypochlorite 0.25% (Half Strength), Sodium hypochlorite 0.5% (Full Strength)

NDC:

0436-0672-16

0436-0936-16

0436-0946-16

Century Pharmaceuticals, Inc. antimicrobial solution.

Product: Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator

Variants: 30 vials per box, Preservative Free

NDC:

0487-2784-01

Nephron Pharmaceuticals Corporation.

Product: Racepinephrine Inhalation Solution, USP 2.25%

Variants: 30 x 0.5 mL Sterile Unit-of-Use Vials, Sulfite Free, Preservative Free

NDC:

0487-5901-99

Nephron Pharmaceuticals Corporation.

Product: Sterile Alcohol Prep Pads

Variants: 100 large pads per box, Latex Free

Model:

1116

NDC:

67777-121-16

Manufactured for Dynarex Corporation.

Product: Alcohol Swabsticks

Variants: 50 4 inch saturated packets per box

Model:

1203

NDC:

67777-300-01

67777-120-10

Manufactured for Dynarex Corporation.

Product: GenTeal Tears Lubricant Eye Ointment

Variants: Night-Time Ointment, 3.5 gm

Model:

30065051801

NDC:

0065-0518-01

Alcon.

Product: Pataday Once Daily Relief (Olopatadine hydrochloride 0.2%)

Variants: 2.5 mL bottle

Model:

00065815001

NDC:

0065-8150-01

Alcon antihistamine eye drops.

Product: A&D Original Ointment

Variants: 16 oz. Jar

NDC:

11523-0096-3

Bayer Healthcare Pharmaceuticals.

Product: Miralax (Polyethylene Glycol 3350)

Variants: 30 Once-Daily Doses, 17.9 OZ (510 g)

Model:

11523723404

NDC:

11523-7234-4

Bayer Healthcare Pharmaceuticals.

Product: Triple Antibiotic Ointment (Honeywell)

Variants: 144 packets per box, 0.5 g per packet

Model:

231209G

NDC:

0498-0750-36

Contains Bacitracin zinc, Neomycin sulfate, and Polymixin B sulfate.

Product: Bisacodyl Suppositories

Variants: 100 suppositories per box, 10 mg each

Model:

444-01-HST

NDC:

57896-443-01

Health Star.

Product: Naphcon A Eye Drops

Variants: 15 mL bottle

Model:

0065008515

NDC:

0065-0085-15

Alcon (Novartis).

Product: Systane Lubricant Eye Drops

Variants: Original Long Lasting, 15 mL bottle, 30 mL bottle

Model:

0065042915

0065042930

NDC:

0065-0429-15

0065-0429-30

Alcon Surgical Inc.

Product: Eye-stream Eye Wash Solution

Variants: 4 FL OZ (118 mL)

Model:

0065053004

NDC:

0065-0530-04

Alcon.

Product: Systane Balance Lubricant Eye Drops

Variants: Restorative Formula, 10 mL bottle

Model:

0065143302

NDC:

0065-1433-02

Alcon.

Product: Systane Zaditor Eye Itch Relief

Variants: 5 mL bottle, 30 day supply

Model:

0065401105

NDC:

0065-4011-05

Alcon.

Product: Debrox Earwax Removal Aid

Variants: 0.5 FL OZ (15 mL)

Model:

04203710478

NDC:

63029-321-01

MedTech Products Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90553

Status: Resolved

Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office

Sold By: McKesson Medical-Surgical Inc.

Manufactured In: United States, Mexico

Units Affected: 16 products (6 boxes; 45 boxes; 12 boxes; 47 bottles; 16 boxes; 12 boxes; 9 boxes; 131 boxes; 67 bottles; 40 boxes; 1 box; 1 Jar; 113 bottles; 1 box; 23 cartons; 10 boxes)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects multiple brands and products including Alcon eye drops (Systane, Pataday, Naphcon A, GenTeal), Bayer products (Miralax, A&D Ointment), Dakin's Solution, Nephron inhalation solutions, and Dynarex alcohol pads.

See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact McKesson Medical-Surgical Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dakin's Solution (473 mL)

Variants: Sodium hypochlorite 0.125% (Quarter Strength), Sodium hypochlorite 0.25% (Half Strength), Sodium hypochlorite 0.5% (Full Strength)

NDC:

0436-0672-16

0436-0936-16

0436-0946-16

Century Pharmaceuticals, Inc. antimicrobial solution.

Product: Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator

Variants: 30 vials per box, Preservative Free

NDC:

0487-2784-01

Nephron Pharmaceuticals Corporation.

Product: Racepinephrine Inhalation Solution, USP 2.25%

Variants: 30 x 0.5 mL Sterile Unit-of-Use Vials, Sulfite Free, Preservative Free

NDC:

0487-5901-99

Nephron Pharmaceuticals Corporation.

Product: Sterile Alcohol Prep Pads

Variants: 100 large pads per box, Latex Free

Model:

1116

NDC:

67777-121-16

Manufactured for Dynarex Corporation.

Product: Alcohol Swabsticks

Variants: 50 4 inch saturated packets per box

Model:

1203

NDC:

67777-300-01

67777-120-10

Manufactured for Dynarex Corporation.

Product: GenTeal Tears Lubricant Eye Ointment

Variants: Night-Time Ointment, 3.5 gm

Model:

30065051801

NDC:

0065-0518-01

Alcon.

Product: Pataday Once Daily Relief (Olopatadine hydrochloride 0.2%)

Variants: 2.5 mL bottle

Model:

00065815001

NDC:

0065-8150-01

Alcon antihistamine eye drops.

Product: A&D Original Ointment

Variants: 16 oz. Jar

NDC:

11523-0096-3

Bayer Healthcare Pharmaceuticals.

Product: Miralax (Polyethylene Glycol 3350)

Variants: 30 Once-Daily Doses, 17.9 OZ (510 g)

Model:

11523723404

NDC:

11523-7234-4

Bayer Healthcare Pharmaceuticals.

Product: Triple Antibiotic Ointment (Honeywell)

Variants: 144 packets per box, 0.5 g per packet

Model:

231209G

NDC:

0498-0750-36

Contains Bacitracin zinc, Neomycin sulfate, and Polymixin B sulfate.

Product: Bisacodyl Suppositories

Variants: 100 suppositories per box, 10 mg each

Model:

444-01-HST

NDC:

57896-443-01

Health Star.

Product: Naphcon A Eye Drops

Variants: 15 mL bottle

Model:

0065008515

NDC:

0065-0085-15

Alcon (Novartis).

Product: Systane Lubricant Eye Drops

Variants: Original Long Lasting, 15 mL bottle, 30 mL bottle

Model:

0065042915

0065042930

NDC:

0065-0429-15

0065-0429-30

Alcon Surgical Inc.

Product: Eye-stream Eye Wash Solution

Variants: 4 FL OZ (118 mL)

Model:

0065053004

NDC:

0065-0530-04

Alcon.

Product: Systane Balance Lubricant Eye Drops

Variants: Restorative Formula, 10 mL bottle

Model:

0065143302

NDC:

0065-1433-02

Alcon.

Product: Systane Zaditor Eye Itch Relief

Variants: 5 mL bottle, 30 day supply

Model:

0065401105

NDC:

0065-4011-05

Alcon.

Product: Debrox Earwax Removal Aid

Variants: 0.5 FL OZ (15 mL)

Model:

04203710478

NDC:

63029-321-01

MedTech Products Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90553

Status: Resolved

Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office

Sold By: McKesson Medical-Surgical Inc.

Manufactured In: United States, Mexico

Units Affected: 16 products (6 boxes; 45 boxes; 12 boxes; 47 bottles; 16 boxes; 12 boxes; 9 boxes; 131 boxes; 67 bottles; 40 boxes; 1 box; 1 Jar; 113 bottles; 1 box; 23 cartons; 10 boxes)

Distributed To: Nationwide