Medications & Supplements/Prescription Drugs

Akorn and AK-POLY-BAC Eye Ointments Recalled for Manufacturing Deficiencies

Agency Publication Date: January 13, 2023

Summary

Akorn, Inc. is recalling 11,318,367 units of various eye drops and ointments, including Tobramycin (tobramycin), AK-POLY-BAC (bacitracin and polymyxin B), and Artificial Tears, because of deviations from good manufacturing practices. These manufacturing deficiencies could affect the quality and sterility of the medications, which are applied directly to the eye. No incidents or injuries have been reported to date. These products were sold nationwide to pharmacies, hospitals, and eye care professionals.

Risk

The manufacturing defects may compromise the sterility and potency of the medications, potentially leading to eye infections or ineffective treatment of existing eye conditions. Because these are ophthalmic products used in a sensitive area, any lack of sterility poses a significant health risk.

What You Should Do

The recalled products include multiple brands and generic versions of eye drops and ointments such as AK-POLY-BAC, GONAK, and solutions containing Tobramycin, Erythromycin, or Timolol Maleate. 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 Akorn, 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: Tobramycin Ophthalmic Solution, USP, 0.3% (5 mL)

Variants: Rx Only

Lot Numbers:

1C56A (EXP 2/28/2023)

1J50A (EXP 8/31/2023)

1K61A (EXP 9/30/2023)

1M27A (EXP 11/30/2023)

NDC:

17478-290-10

Product: Tobramycin Ophthalmic Solution, USP, 0.3% (5 mL)

Variants: Distributed by MWI

Lot Numbers:

1D94A (EXP 3/31/2023)

1E35A (EXP 4/30/2023)

2A06A (EXP 12/31/2023)

NDC:

13985-604-05

Product: AK-POLY-BAC brand of Bacitracin and Polymixin B Sulfate Ophthalmic Ointment USP (3.5 g)

Variants: Rx only, Sterile

Lot Numbers:

0G87A (EXP 06/30/2023)

NDC:

17478-238-35

Product: Artificial Tears OINTMENT, Lubricant Eye Ointment (3.5 g)

Variants: Sterile

Lot Numbers:

0A08B (EXP 12/31/2022)

0B63A (EXP 1/31/2023)

0C72A (EXP 2/28/2023)

0D14A (EXP 3/31/2023)

0D19A (EXP 3/31/2023)

0F54A (EXP 5/31/2023)

0G80B (EXP 6/30/2023)

0G09B (EXP 6/30/2023)

0G97A (EXP 6/30/2023)

0J78A (EXP 8/31/2023)

0K23A (EXP 9/30/2023)

0L64A (EXP 10/31/2023)

1B29A (EXP 1/31/2024)

1C59A (EXP 2/29/2024)

1C53A (EXP 2/29/2024)

1C72A (EXP 2/29/2024)

1C78A (EXP 2/29/2024)

1D87A (EXP 3/31/2024)

1D89A (EXP 3/31/2024)

1G59A (EXP 6/30/2024)

1G59B (EXP 6/30/2024)

1K60A (EXP 9/30/2024)

1J57A (EXP 8/31/2024)

1H86A (EXP 7/31/2024)

1K75A (EXP 9/30/2024)

1L12A (EXP 10/31/2024)

1M22A (EXP 11/30/2024)

NDC:

17478-062-35

Product: Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4% (15 mL)

Variants: Sterile

Lot Numbers:

0L44A (EXP 10/31/2022)

0L52A (EXP 10/31/2022)

0L51A (EXP 10/31/2022)

0L77A (EXP 10/31/2022)

0L75A (EXP 10/31/2022)

0M02A (EXP 11/30/2022)

0M01A (EXP 11/30/2022)

1C81A (EXP 2/28/2023)

1D02A (EXP 3/31/2023)

1D03A (EXP 3/31/2023)

1E10A (EXP 4/30/2023)

1E08A (EXP 4/30/2023)

1E23A (EXP 4/30/2023)

1E26A (EXP 4/30/2023)

1E25A (EXP 4/30/2023)

1E27A (EXP 4/30/2023)

1E33A (EXP 4/30/2023)

1F46A (EXP 5/31/2023)

1G49A (EXP 6/30/2023)

1G50A (EXP 6/30/2023)

1G67A (EXP 6/30/2023)

1H04A (EXP 7/31/2023)

1H74A (EXP 7/31/2023)

1H76A (EXP 7/31/2023)

1H05A (EXP 7/31/2023)

1H07A (EXP 7/31/2023)

1H15A (EXP 7/31/2023)

1H13A (EXP 7/31/2023)

1H95A (EXP 7/31/2023)

1J44A (EXP 8/31/2023)

1J20A (EXP 8/31/2023)

NDC:

17478-060-12

Product: Betaxolol Ophthalmic Solution, USP 0.5% (5 mL)

Variants: Rx Only, Sterile

Lot Numbers:

1A08A (EXP 12/31/2022)

NDC:

17478-705-10

Product: Ciprofloxacin Ophthalmic Solution, USP 0.3% (2.5 mL)

Variants: Rx Only

Lot Numbers:

1E22A (EXP 10/31/2022)

NDC:

17478-714-25

Product: Cromolyn Sodium Ophthalmic Solution, USP 4% (10 mL)

Variants: Rx Only

Lot Numbers:

0G75A (EXP 6/30/2023)

0G12A (EXP 6/30/2023)

0H50A (EXP 7/31/2023)

0J88A (EXP 8/31/2023)

1D98A (EXP 3/31/2024)

1E31A (EXP 4/30/2024)

1D97A (EXP 3/31/2024)

1H14A (EXP 7/31/2024)

NDC:

17478-291-11

Product: ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5% (3.5 g)

Variants: Rx Only

Lot Numbers:

0L58A (EXP 10/31/2022)

1B21A (EXP 1/31/2023)

1B31A (EXP 1/31/2023)

1C44A (EXP 2/28/2023)

1C58A (EXP 2/28/2023)

1C58B (EXP 2/28/2023)

1E13A (EXP 4/30/2023)

1E24A (EXP 4/30/2023)

1C57A (EXP 2/28/2023)

1G60A (EXP 6/30/2023)

1G62A (EXP 6/30/2023)

1G63A (EXP 6/30/2023)

1J34B (EXP 8/31/2023)

1J40A (EXP 8/31/2023)

1J21A (EXP 8/31/2023)

1K74A (EXP 9/30/2023)

1L93A (EXP 10/31/2023)

1L96B (EXP 10/31/2023)

1L96A (EXP 10/31/2023)

1M25A (EXP 11/30/2023)

1M24A (EXP 11/30/2023)

1M31A (EXP 11/30/2023)

2A02A (EXP 12/31/2023)

2A10A (EXP 12/31/2023)

2C07A (EXP 2/29/2024)

2D47A (EXP 3/31/2024)

2E50A (EXP 4/30/2024)

2E51A (EXP 4/30/2024)

NDC:

17478-070-35

Product: Erythromycin Ophthalmic Ointment USP, 0.5% (1 g)

Variants: Rx Only, 50 unit-dose tubes per carton

Lot Numbers:

1B14B (EXP 1/31/2023)

1C49A (EXP 2/28/2023)

1C49B (EXP 2/28/2023)

1C70A (EXP 2/28/2023)

1E09A (EXP 4/30/2023)

1E34A (EXP 4/30/2023)

1E34B (EXP 4/30/2023)

1E09B (EXP 4/30/2023)

1F37C (EXP 5/31/2023)

1F37A (EXP 5/31/2023)

1F37B (EXP 5/31/2023)

1G58A (EXP 6/30/2023)

1G57B (EXP 6/30/2023)

1G58B (EXP 6/30/2023)

1G66B (EXP 6/30/2023)

1G66A (EXP 6/30/2023)

1G57A (EXP 6/30/2023)

1H77B (EXP 7/31/2023)

1H80A (EXP 7/31/2023)

1H80B (EXP 7/31/2023)

1H77A (EXP 7/31/2023)

1J24A (EXP 8/31/2023)

1K67B (EXP 9/30/2023)

1K67A (EXP 9/30/2023)

1K76A (EXP 9/30/2023)

1K87B (EXP 9/30/2023)

1K77A (EXP 9/30/2023)

1K76B (EXP 9/30/2023)

1K87A (EXP 9/30/2023)

1K77B (EXP 9/30/2023)

1L90B (EXP 10/31/2023)

1L90A (EXP 10/31/2023)

1L92B (EXP 10/31/2023)

1L92A (EXP 10/31/2023)

1M28A (EXP 11/30/2023)

1M35A (EXP 11/30/2023)

1M28B (EXP 11/30/2023)

2D20B (EXP 3/31/2024)

NDC:

17478-070-31

Product: GONAK Hypromellose Ophthalmic Demulcent Solution, 2.5% (15 mL)

Variants: Professional Use

Lot Numbers:

0C80A (EXP 2/28/2023)

0B71A (EXP 1/31/2023)

1B32A (EXP 1/31/2023)

0C80B (EXP 2/28/2023)

0F68A (EXP 5/31/2023)

0G85A (EXP 6/30/2023)

0G01A (EXP 6/30/2023)

1G54A (EXP 6/30/2023)

1G71A (EXP 6/30/2023)

0H32A (EXP 7/31/2023)

0H47A (EXP 7/31/2023)

1H75A (EXP 7/31/2023)

0K22A (EXP 9/30/2023)

0M90A (EXP 11/30/2023)

NDC:

17478-064-12

Product: Ketorolac Tromethamine Ophthalmic Solution, 0.5%

Variants: Rx Only, 3 mL, 5 mL, 10 mL

Lot Numbers:

1A09A (EXP 12/31/2022)

1H01A (EXP 7/31/2023)

1E32A (EXP 4/30/2023)

1F45A (EXP 5/31/2023)

1H99A (EXP 7/31/2023)

1K84A (EXP 9/30/2023)

0L40A (EXP 10/31/2022)

1B38A (EXP 1/31/2023)

1E12A (EXP 4/30/2023)

1F41A (EXP 5/31/2023)

1G73A (EXP 6/30/2023)

1G68A (EXP 6/30/2023)

1H08A (EXP 7/31/2023)

1H12A (EXP 7/31/2023)

NDC:

17478-209-11

17478-209-19

17478-209-10

Product: Levofloxacin Ophthalmic Solution 0.5% (5 mL)

Variants: Rx Only

Lot Numbers:

1F43A (EXP 5/31/2023)

NDC:

17478-106-10

Product: Lidocaine Hydrochloride Jelly USP, 2%

Variants: Rx Only, 5 mL tube, 30 mL tube

Lot Numbers (109):

0A02B (EXP 12/31/2022)

0A02D (EXP 12/31/2022)

0A02C (EXP 12/31/2022)

0A02A (EXP 12/31/2022)

0A02E (EXP 12/31/2022)

0B60C (EXP 1/31/2023)

0B46B (EXP 1/31/2023)

0B60D (EXP 1/31/2023)

0B67B (EXP 1/31/2023)

0B67D (EXP 1/31/2023)

0B60B (EXP 1/31/2023)

0B60A (EXP 1/31/2023)

0B67A (EXP 1/31/2023)

0B46D (EXP 1/31/2023)

0B67C (EXP 1/31/2023)

0B46A (EXP 1/31/2023)

0C78B (EXP 2/28/2023)

0C78D (EXP 2/28/2023)

0C78C (EXP 2/28/2023)

0D11A (EXP 3/31/2023)

0D11C (EXP 3/31/2023)

0D11B (EXP 3/31/2023)

0D11D (EXP 3/31/2023)

0E35C (EXP 4/30/2023)

0E35B (EXP 4/30/2023)

0E35A (EXP 4/30/2023)

0J63B (EXP 8/31/2023)

0J63C (EXP 8/31/2023)

0K02A (EXP 9/30/2023)

0K02C (EXP 9/30/2023)

0K02D (EXP 9/30/2023)

0K02B (EXP 9/30/2023)

0L47B (EXP 10/31/2023)

0L47C (EXP 10/31/2023)

0L47A (EXP 10/31/2023)

1B12B (EXP 1/31/2024)

1B12A (EXP 1/31/2024)

1B23A (EXP 1/31/2024)

1B23F (EXP 1/31/2024)

1B12C (EXP 1/31/2024)

1B23B (EXP 1/31/2024)

1B23D (EXP 1/31/2024)

1B23E (EXP 1/31/2024)

1B12D (EXP 1/31/2024)

1C66C (EXP 2/29/2024)

1C66A (EXP 2/29/2024)

1D93B (EXP 3/31/2024)

1D93D (EXP 3/31/2024)

1D93C (EXP 3/31/2024)

1D99B (EXP 3/31/2024)

NDC:

17478-711-10

17478-711-31

17478-711-30

Product: Moxifloxacin Ophthalmic Solution, USP, 0.5% (3 mL)

Variants: Rx only

Lot Numbers:

1E28A (EXP 4/30/2023)

NDC:

17478-519-19

Product: Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP (3.5 g)

Variants: Rx Only

Lot Numbers:

1K64A (EXP 9/30/2023)

NDC:

17478-235-35

Product: Ofloxacin Ophthalmic Solution, USP 0.3% (5 mL)

Variants: Rx Only, Distributed by MWI

Lot Numbers:

11B26A (EXP 1/31/2023)

1H02A (EXP 7/31/2023)

NDC:

13985-602-05

Product: Olopatadine HCl Ophthalmic Solution, USP 0.1% (5 mL)

Variants: Rx Only

Lot Numbers:

1B41A (EXP 1/31/2023)

NDC:

17478-105-05

Product: Olopatadine HCL Ophthalmic Solution, USP 0.1% (5 mL)

Variants: Antihistamine and Redness Reliever

Lot Numbers:

1L03A (EXP 10/31/2023)

NDC:

17478-308-05

Product: Olopatadine HCl Ophthalmic Solution, USP 0.2% (2.5 mL)

Variants: Rx Only

Lot Numbers:

0L48A (EXP 10/31/2022)

0L55A (EXP 10/31/2022)

1C75A (EXP 2/28/2023)

1E18A (EXP 4/30/2023)

1E20A (EXP 4/30/2023)

NDC:

17478-305-12

Product: Olopatadine HCl Ophthalmic Solution, USP 0.1% (5 mL)

Variants: Antihistamine and Redness Reliever, Marketed by GSMS, Incorporated

Lot Numbers:

1L16A (EXP 10/31/2023)

1L17A (EXP 10/31/2023)

1M29A (EXP 11/30/2023)

2A05A (EXP 12/31/2023)

NDC:

51407-499-05

Product: Olopatadine HCl Ophthalmic Solution, USP 0.1% (5 mL)

Variants: Rx Only, Marketed by GSMS, Incorporated

Lot Numbers:

1C61A (EXP 2/28/2023)

1D86A (EXP 3/31/2023)

1D07A (EXP 3/31/2023)

NDC:

60429-957-05

Product: PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25% (15 mL)

Variants: Rx only

Lot Numbers:

0B55A (EXP 1/31/2023)

0D16A (EXP 3/31/2023)

0D23A (EXP 3/31/2023)

0E51A (EXP 4/30/2023)

1C46A (EXP 2/29/2024)

NDC:

17478-704-12

Product: Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (15 mL)

Variants: Rx only, Distributed by Akorn Operating Company LLC

Lot Numbers:

0L42A (EXP 10/31/2022)

0L50A (EXP 10/31/2022)

1C64A (EXP 2/28/2023)

1C76A (EXP 2/28/2023)

1G53A (EXP 6/30/2023)

1J26A (EXP 8/31/2023)

1J25A (EXP 8/31/2023)

1J48A (EXP 8/31/2023)

1J54A (EXP 8/31/2023)

NDC:

17478-263-12

Product: Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (15 mL)

Variants: Rx only, Distributed by MWI

Lot Numbers:

0L53A (EXP 10/31/2022)

1J49A (EXP 8/31/2023)

NDC:

13985-611-15

Product: Sodium Chloride Ophthalmic Ointment, USP, 5% (3.5 g)

Lot Numbers:

0F69A (EXP 5/31/2023)

0G92B (EXP 6/30/2023)

0G92A (EXP 6/30/2023)

0J69A (EXP 8/31/2023)

0K29A (EXP 9/30/2023)

0K24A (EXP 9/30/2023)

0M93A (EXP 11/30/2023)

0M92A (EXP 11/30/2023)

0M92B (EXP 11/30/2023)

1B25A (EXP 1/31/2024)

1C74A (EXP 2/29/2024)

1E19A (EXP 4/30/2024)

1C77A (EXP 2/29/2024)

NDC:

17478-622-35

Product: Timolol Maleate Ophthalmic Solution, USP, 0.5%

Variants: Rx Only, Sterile, 5 mL, 10 mL, 15 mL

Lot Numbers (57):

0B50A (EXP 1/31/2023)

0B69A (EXP 1/31/2023)

0C74A (EXP 2/28/2023)

0D04A (EXP 3/31/2023)

0E37A (EXP 4/30/2023)

0G07A (EXP 6/30/2023)

0G82A (EXP 6/30/2023)

0H26A (EXP 7/31/2023)

0H28A (EXP 7/31/2023)

0H53A (EXP 7/31/2023)

0H36A (EXP 7/31/2023)

0J64A (EXP 8/31/2023)

0J58A (EXP 8/31/2023)

0J66A (EXP 8/31/2023)

0K96A (EXP 9/30/2023)

0K06A (EXP 9/30/2023)

0K98A (EXP 9/30/2023)

0K04A (EXP 9/30/2023)

0K03A (EXP 9/30/2023)

0K99A (EXP 9/30/2023)

0L72A (EXP 10/31/2023)

0M81A (EXP 11/30/2023)

0M85A (EXP 11/30/2023)

0M80A (EXP 11/30/2023)

0M84A (EXP 11/30/2023)

0M82A (EXP 11/30/2023)

0M83A (EXP 11/30/2023)

1A01A (EXP 12/31/2023)

1A02A (EXP 12/31/2023)

1B16A (EXP 1/31/2024)

1B13A (EXP 1/31/2024)

1B17A (EXP 1/31/2024)

1C51A (EXP 2/29/2024)

0B59A (EXP 1/31/2023)

0E49A (EXP 4/30/2023)

0G14A (EXP 6/30/2023)

0H38A (EXP 7/31/2023)

0J84A (EXP 8/31/2023)

0K05A (EXP 9/30/2023)

0L59A (EXP 10/31/2023)

0M86A (EXP 11/30/2023)

0M87A (EXP 11/30/2023)

1A03A (EXP 12/31/2023)

1B37A (EXP 1/31/2024)

1C63A (EXP 2/29/2024)

1C54A (EXP 2/29/2024)

1D83A (EXP 3/31/2024)

0C82A (EXP 2/28/2023)

0G84A (EXP 6/30/2023)

0H49A (EXP 7/31/2023)

NDC:

17478-288-10

17478-288-11

17478-288-12

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90948

Status: Active

Manufacturer: Akorn, Inc.

Sold By: MWI; GSMS, Incorporated; pharmacies; hospitals; eye care professionals

Manufactured In: United States

Units Affected: 27 products (36,025 tubes; 1,164,171 tubes; 967,075 bottles; 6,273 bottles; 1,584 bottles; 188,550 bottles; 1,109,600 tubes; 36,455 cartons; 196,254 bottles; 314,543 10ml,3ml, 5ml bottles; 3108 bottles; 2,369,258 tubes; 2,563 bottles; 2,082 tubes; 65,006 bottles; 31,073 bottles; 1,752 bottles; 173,928 bottles; 163,996 bottles; 121,176 bottles; 51,601 bottles; 267,678 bottles; 23,026 bottles; 524,506 tubes; 1,310,324 bottles; 2,095,068 bottles; 91,692 bottles)

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

The recalled products include multiple brands and generic versions of eye drops and ointments such as AK-POLY-BAC, GONAK, and solutions containing Tobramycin, Erythromycin, or Timolol Maleate. 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 Akorn, 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: Tobramycin Ophthalmic Solution, USP, 0.3% (5 mL)

Variants: Rx Only

Lot Numbers:

1C56A (EXP 2/28/2023)

1J50A (EXP 8/31/2023)

1K61A (EXP 9/30/2023)

1M27A (EXP 11/30/2023)

NDC:

17478-290-10

Product: Tobramycin Ophthalmic Solution, USP, 0.3% (5 mL)

Variants: Distributed by MWI

Lot Numbers:

1D94A (EXP 3/31/2023)

1E35A (EXP 4/30/2023)

2A06A (EXP 12/31/2023)

NDC:

13985-604-05

Product: AK-POLY-BAC brand of Bacitracin and Polymixin B Sulfate Ophthalmic Ointment USP (3.5 g)

Variants: Rx only, Sterile

Lot Numbers:

0G87A (EXP 06/30/2023)

NDC:

17478-238-35

Product: Artificial Tears OINTMENT, Lubricant Eye Ointment (3.5 g)

Variants: Sterile

Lot Numbers:

0A08B (EXP 12/31/2022)

0B63A (EXP 1/31/2023)

0C72A (EXP 2/28/2023)

0D14A (EXP 3/31/2023)

0D19A (EXP 3/31/2023)

0F54A (EXP 5/31/2023)

0G80B (EXP 6/30/2023)

0G09B (EXP 6/30/2023)

0G97A (EXP 6/30/2023)

0J78A (EXP 8/31/2023)

0K23A (EXP 9/30/2023)

0L64A (EXP 10/31/2023)

1B29A (EXP 1/31/2024)

1C59A (EXP 2/29/2024)

1C53A (EXP 2/29/2024)

1C72A (EXP 2/29/2024)

1C78A (EXP 2/29/2024)

1D87A (EXP 3/31/2024)

1D89A (EXP 3/31/2024)

1G59A (EXP 6/30/2024)

1G59B (EXP 6/30/2024)

1K60A (EXP 9/30/2024)

1J57A (EXP 8/31/2024)

1H86A (EXP 7/31/2024)

1K75A (EXP 9/30/2024)

1L12A (EXP 10/31/2024)

1M22A (EXP 11/30/2024)

NDC:

17478-062-35

Product: Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4% (15 mL)

Variants: Sterile

Lot Numbers:

0L44A (EXP 10/31/2022)

0L52A (EXP 10/31/2022)

0L51A (EXP 10/31/2022)

0L77A (EXP 10/31/2022)

0L75A (EXP 10/31/2022)

0M02A (EXP 11/30/2022)

0M01A (EXP 11/30/2022)

1C81A (EXP 2/28/2023)

1D02A (EXP 3/31/2023)

1D03A (EXP 3/31/2023)

1E10A (EXP 4/30/2023)

1E08A (EXP 4/30/2023)

1E23A (EXP 4/30/2023)

1E26A (EXP 4/30/2023)

1E25A (EXP 4/30/2023)

1E27A (EXP 4/30/2023)

1E33A (EXP 4/30/2023)

1F46A (EXP 5/31/2023)

1G49A (EXP 6/30/2023)

1G50A (EXP 6/30/2023)

1G67A (EXP 6/30/2023)

1H04A (EXP 7/31/2023)

1H74A (EXP 7/31/2023)

1H76A (EXP 7/31/2023)

1H05A (EXP 7/31/2023)

1H07A (EXP 7/31/2023)

1H15A (EXP 7/31/2023)

1H13A (EXP 7/31/2023)

1H95A (EXP 7/31/2023)

1J44A (EXP 8/31/2023)

1J20A (EXP 8/31/2023)

NDC:

17478-060-12

Product: Betaxolol Ophthalmic Solution, USP 0.5% (5 mL)

Variants: Rx Only, Sterile

Lot Numbers:

1A08A (EXP 12/31/2022)

NDC:

17478-705-10

Product: Ciprofloxacin Ophthalmic Solution, USP 0.3% (2.5 mL)

Variants: Rx Only

Lot Numbers:

1E22A (EXP 10/31/2022)

NDC:

17478-714-25

Product: Cromolyn Sodium Ophthalmic Solution, USP 4% (10 mL)

Variants: Rx Only

Lot Numbers:

0G75A (EXP 6/30/2023)

0G12A (EXP 6/30/2023)

0H50A (EXP 7/31/2023)

0J88A (EXP 8/31/2023)

1D98A (EXP 3/31/2024)

1E31A (EXP 4/30/2024)

1D97A (EXP 3/31/2024)

1H14A (EXP 7/31/2024)

NDC:

17478-291-11

Product: ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5% (3.5 g)

Variants: Rx Only

Lot Numbers:

0L58A (EXP 10/31/2022)

1B21A (EXP 1/31/2023)

1B31A (EXP 1/31/2023)

1C44A (EXP 2/28/2023)

1C58A (EXP 2/28/2023)

1C58B (EXP 2/28/2023)

1E13A (EXP 4/30/2023)

1E24A (EXP 4/30/2023)

1C57A (EXP 2/28/2023)

1G60A (EXP 6/30/2023)

1G62A (EXP 6/30/2023)

1G63A (EXP 6/30/2023)

1J34B (EXP 8/31/2023)

1J40A (EXP 8/31/2023)

1J21A (EXP 8/31/2023)

1K74A (EXP 9/30/2023)

1L93A (EXP 10/31/2023)

1L96B (EXP 10/31/2023)

1L96A (EXP 10/31/2023)

1M25A (EXP 11/30/2023)

1M24A (EXP 11/30/2023)

1M31A (EXP 11/30/2023)

2A02A (EXP 12/31/2023)

2A10A (EXP 12/31/2023)

2C07A (EXP 2/29/2024)

2D47A (EXP 3/31/2024)

2E50A (EXP 4/30/2024)

2E51A (EXP 4/30/2024)

NDC:

17478-070-35

Product: Erythromycin Ophthalmic Ointment USP, 0.5% (1 g)

Variants: Rx Only, 50 unit-dose tubes per carton

Lot Numbers:

1B14B (EXP 1/31/2023)

1C49A (EXP 2/28/2023)

1C49B (EXP 2/28/2023)

1C70A (EXP 2/28/2023)

1E09A (EXP 4/30/2023)

1E34A (EXP 4/30/2023)

1E34B (EXP 4/30/2023)

1E09B (EXP 4/30/2023)

1F37C (EXP 5/31/2023)

1F37A (EXP 5/31/2023)

1F37B (EXP 5/31/2023)

1G58A (EXP 6/30/2023)

1G57B (EXP 6/30/2023)

1G58B (EXP 6/30/2023)

1G66B (EXP 6/30/2023)

1G66A (EXP 6/30/2023)

1G57A (EXP 6/30/2023)

1H77B (EXP 7/31/2023)

1H80A (EXP 7/31/2023)

1H80B (EXP 7/31/2023)

1H77A (EXP 7/31/2023)

1J24A (EXP 8/31/2023)

1K67B (EXP 9/30/2023)

1K67A (EXP 9/30/2023)

1K76A (EXP 9/30/2023)

1K87B (EXP 9/30/2023)

1K77A (EXP 9/30/2023)

1K76B (EXP 9/30/2023)

1K87A (EXP 9/30/2023)

1K77B (EXP 9/30/2023)

1L90B (EXP 10/31/2023)

1L90A (EXP 10/31/2023)

1L92B (EXP 10/31/2023)

1L92A (EXP 10/31/2023)

1M28A (EXP 11/30/2023)

1M35A (EXP 11/30/2023)

1M28B (EXP 11/30/2023)

2D20B (EXP 3/31/2024)

NDC:

17478-070-31

Product: GONAK Hypromellose Ophthalmic Demulcent Solution, 2.5% (15 mL)

Variants: Professional Use

Lot Numbers:

0C80A (EXP 2/28/2023)

0B71A (EXP 1/31/2023)

1B32A (EXP 1/31/2023)

0C80B (EXP 2/28/2023)

0F68A (EXP 5/31/2023)

0G85A (EXP 6/30/2023)

0G01A (EXP 6/30/2023)

1G54A (EXP 6/30/2023)

1G71A (EXP 6/30/2023)

0H32A (EXP 7/31/2023)

0H47A (EXP 7/31/2023)

1H75A (EXP 7/31/2023)

0K22A (EXP 9/30/2023)

0M90A (EXP 11/30/2023)

NDC:

17478-064-12

Product: Ketorolac Tromethamine Ophthalmic Solution, 0.5%

Variants: Rx Only, 3 mL, 5 mL, 10 mL

Lot Numbers:

1A09A (EXP 12/31/2022)

1H01A (EXP 7/31/2023)

1E32A (EXP 4/30/2023)

1F45A (EXP 5/31/2023)

1H99A (EXP 7/31/2023)

1K84A (EXP 9/30/2023)

0L40A (EXP 10/31/2022)

1B38A (EXP 1/31/2023)

1E12A (EXP 4/30/2023)

1F41A (EXP 5/31/2023)

1G73A (EXP 6/30/2023)

1G68A (EXP 6/30/2023)

1H08A (EXP 7/31/2023)

1H12A (EXP 7/31/2023)

NDC:

17478-209-11

17478-209-19

17478-209-10

Product: Levofloxacin Ophthalmic Solution 0.5% (5 mL)

Variants: Rx Only

Lot Numbers:

1F43A (EXP 5/31/2023)

NDC:

17478-106-10

Product: Lidocaine Hydrochloride Jelly USP, 2%

Variants: Rx Only, 5 mL tube, 30 mL tube

Lot Numbers (109):

0A02B (EXP 12/31/2022)

0A02D (EXP 12/31/2022)

0A02C (EXP 12/31/2022)

0A02A (EXP 12/31/2022)

0A02E (EXP 12/31/2022)

0B60C (EXP 1/31/2023)

0B46B (EXP 1/31/2023)

0B60D (EXP 1/31/2023)

0B67B (EXP 1/31/2023)

0B67D (EXP 1/31/2023)

0B60B (EXP 1/31/2023)

0B60A (EXP 1/31/2023)

0B67A (EXP 1/31/2023)

0B46D (EXP 1/31/2023)

0B67C (EXP 1/31/2023)

0B46A (EXP 1/31/2023)

0C78B (EXP 2/28/2023)

0C78D (EXP 2/28/2023)

0C78C (EXP 2/28/2023)

0D11A (EXP 3/31/2023)

0D11C (EXP 3/31/2023)

0D11B (EXP 3/31/2023)

0D11D (EXP 3/31/2023)

0E35C (EXP 4/30/2023)

0E35B (EXP 4/30/2023)

0E35A (EXP 4/30/2023)

0J63B (EXP 8/31/2023)

0J63C (EXP 8/31/2023)

0K02A (EXP 9/30/2023)

0K02C (EXP 9/30/2023)

0K02D (EXP 9/30/2023)

0K02B (EXP 9/30/2023)

0L47B (EXP 10/31/2023)

0L47C (EXP 10/31/2023)

0L47A (EXP 10/31/2023)

1B12B (EXP 1/31/2024)

1B12A (EXP 1/31/2024)

1B23A (EXP 1/31/2024)

1B23F (EXP 1/31/2024)

1B12C (EXP 1/31/2024)

1B23B (EXP 1/31/2024)

1B23D (EXP 1/31/2024)

1B23E (EXP 1/31/2024)

1B12D (EXP 1/31/2024)

1C66C (EXP 2/29/2024)

1C66A (EXP 2/29/2024)

1D93B (EXP 3/31/2024)

1D93D (EXP 3/31/2024)

1D93C (EXP 3/31/2024)

1D99B (EXP 3/31/2024)

NDC:

17478-711-10

17478-711-31

17478-711-30

Product: Moxifloxacin Ophthalmic Solution, USP, 0.5% (3 mL)

Variants: Rx only

Lot Numbers:

1E28A (EXP 4/30/2023)

NDC:

17478-519-19

Product: Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP (3.5 g)

Variants: Rx Only

Lot Numbers:

1K64A (EXP 9/30/2023)

NDC:

17478-235-35

Product: Ofloxacin Ophthalmic Solution, USP 0.3% (5 mL)

Variants: Rx Only, Distributed by MWI

Lot Numbers:

11B26A (EXP 1/31/2023)

1H02A (EXP 7/31/2023)

NDC:

13985-602-05

Product: Olopatadine HCl Ophthalmic Solution, USP 0.1% (5 mL)

Variants: Rx Only

Lot Numbers:

1B41A (EXP 1/31/2023)

NDC:

17478-105-05

Product: Olopatadine HCL Ophthalmic Solution, USP 0.1% (5 mL)

Variants: Antihistamine and Redness Reliever

Lot Numbers:

1L03A (EXP 10/31/2023)

NDC:

17478-308-05

Product: Olopatadine HCl Ophthalmic Solution, USP 0.2% (2.5 mL)

Variants: Rx Only

Lot Numbers:

0L48A (EXP 10/31/2022)

0L55A (EXP 10/31/2022)

1C75A (EXP 2/28/2023)

1E18A (EXP 4/30/2023)

1E20A (EXP 4/30/2023)

NDC:

17478-305-12

Product: Olopatadine HCl Ophthalmic Solution, USP 0.1% (5 mL)

Variants: Antihistamine and Redness Reliever, Marketed by GSMS, Incorporated

Lot Numbers:

1L16A (EXP 10/31/2023)

1L17A (EXP 10/31/2023)

1M29A (EXP 11/30/2023)

2A05A (EXP 12/31/2023)

NDC:

51407-499-05

Product: Olopatadine HCl Ophthalmic Solution, USP 0.1% (5 mL)

Variants: Rx Only, Marketed by GSMS, Incorporated

Lot Numbers:

1C61A (EXP 2/28/2023)

1D86A (EXP 3/31/2023)

1D07A (EXP 3/31/2023)

NDC:

60429-957-05

Product: PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25% (15 mL)

Variants: Rx only

Lot Numbers:

0B55A (EXP 1/31/2023)

0D16A (EXP 3/31/2023)

0D23A (EXP 3/31/2023)

0E51A (EXP 4/30/2023)

1C46A (EXP 2/29/2024)

NDC:

17478-704-12

Product: Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (15 mL)

Variants: Rx only, Distributed by Akorn Operating Company LLC

Lot Numbers:

0L42A (EXP 10/31/2022)

0L50A (EXP 10/31/2022)

1C64A (EXP 2/28/2023)

1C76A (EXP 2/28/2023)

1G53A (EXP 6/30/2023)

1J26A (EXP 8/31/2023)

1J25A (EXP 8/31/2023)

1J48A (EXP 8/31/2023)

1J54A (EXP 8/31/2023)

NDC:

17478-263-12

Product: Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (15 mL)

Variants: Rx only, Distributed by MWI

Lot Numbers:

0L53A (EXP 10/31/2022)

1J49A (EXP 8/31/2023)

NDC:

13985-611-15

Product: Sodium Chloride Ophthalmic Ointment, USP, 5% (3.5 g)

Lot Numbers:

0F69A (EXP 5/31/2023)

0G92B (EXP 6/30/2023)

0G92A (EXP 6/30/2023)

0J69A (EXP 8/31/2023)

0K29A (EXP 9/30/2023)

0K24A (EXP 9/30/2023)

0M93A (EXP 11/30/2023)

0M92A (EXP 11/30/2023)

0M92B (EXP 11/30/2023)

1B25A (EXP 1/31/2024)

1C74A (EXP 2/29/2024)

1E19A (EXP 4/30/2024)

1C77A (EXP 2/29/2024)

NDC:

17478-622-35

Product: Timolol Maleate Ophthalmic Solution, USP, 0.5%

Variants: Rx Only, Sterile, 5 mL, 10 mL, 15 mL

Lot Numbers (57):

0B50A (EXP 1/31/2023)

0B69A (EXP 1/31/2023)

0C74A (EXP 2/28/2023)

0D04A (EXP 3/31/2023)

0E37A (EXP 4/30/2023)

0G07A (EXP 6/30/2023)

0G82A (EXP 6/30/2023)

0H26A (EXP 7/31/2023)

0H28A (EXP 7/31/2023)

0H53A (EXP 7/31/2023)

0H36A (EXP 7/31/2023)

0J64A (EXP 8/31/2023)

0J58A (EXP 8/31/2023)

0J66A (EXP 8/31/2023)

0K96A (EXP 9/30/2023)

0K06A (EXP 9/30/2023)

0K98A (EXP 9/30/2023)

0K04A (EXP 9/30/2023)

0K03A (EXP 9/30/2023)

0K99A (EXP 9/30/2023)

0L72A (EXP 10/31/2023)

0M81A (EXP 11/30/2023)

0M85A (EXP 11/30/2023)

0M80A (EXP 11/30/2023)

0M84A (EXP 11/30/2023)

0M82A (EXP 11/30/2023)

0M83A (EXP 11/30/2023)

1A01A (EXP 12/31/2023)

1A02A (EXP 12/31/2023)

1B16A (EXP 1/31/2024)

1B13A (EXP 1/31/2024)

1B17A (EXP 1/31/2024)

1C51A (EXP 2/29/2024)

0B59A (EXP 1/31/2023)

0E49A (EXP 4/30/2023)

0G14A (EXP 6/30/2023)

0H38A (EXP 7/31/2023)

0J84A (EXP 8/31/2023)

0K05A (EXP 9/30/2023)

0L59A (EXP 10/31/2023)

0M86A (EXP 11/30/2023)

0M87A (EXP 11/30/2023)

1A03A (EXP 12/31/2023)

1B37A (EXP 1/31/2024)

1C63A (EXP 2/29/2024)

1C54A (EXP 2/29/2024)

1D83A (EXP 3/31/2024)

0C82A (EXP 2/28/2023)

0G84A (EXP 6/30/2023)

0H49A (EXP 7/31/2023)

NDC:

17478-288-10

17478-288-11

17478-288-12

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90948

Status: Active

Manufacturer: Akorn, Inc.

Sold By: MWI; GSMS, Incorporated; pharmacies; hospitals; eye care professionals

Manufactured In: United States

Distributed To: Nationwide