APS Pharmacy Ophthalmic Solutions Recalled for Lack of Sterility

Agency Publication Date: March 27, 2022

Summary

Drug Depot, Inc., doing business as APS Pharmacy, is recalling 383 units of various veterinary ophthalmic (eye) solutions due to a lack of sterility assurance. These sterile eye medications, which include Tacrolimus and Cyclosporine, were distributed in small droptainers across the United States. While no injuries or infections have been reported to date, products intended to be sterile that lack proper assurance can cause serious eye infections in animals.

Risk

The lack of sterility assurance means these eye drops may contain microorganisms that can lead to severe infections or sight-threatening complications when applied to an animal's eye.

What You Should Do

Check your pet's eye medication for Tacrolimus 0.03% (5 mL or 10 mL), Tacrolimus 0.02% (5 mL or 10 mL), or Cyclosporine 0.1%, 0.2%, or 2% (5 mL or 10 mL).
Look for the following lot numbers and Beyond Use Dates (BUD): 745456 (3/22/2022), 749007 (4/11/2022), 751293 (4/20/2022), 755647 (5/9/2022), 757809 (5/18/2022), 758301 (5/26/2022), 750622 (6/30/2022), 749299 (6/30/2022), 754281 (6/30/2022), 756306 (6/30/2022), or 757939 (8/23/2022).
If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact APS Pharmacy for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: Tacrolimus 0.03% OPHTH SOL (Vet Use Only)

Variants: 5 mL, 10 mL

Model:

V-0057-2022

V-0059-2022

Lot Numbers:

745456 (BUD: 3/22/2022)

749007 (BUD: 4/11/2022)

758301 (BUD: 5/26/2022)

Recall numbers V-0057-2022 and V-0059-2022 combined as variants of same concentration.

Product: Tacrolimus 0.02% OPHTH SOL (Vet Use Only)

Variants: 5 mL, 10 mL

Model:

V-0058-2022

Lot Numbers:

751293 (BUD: 4/20/2022)

755647 (BUD: 5/9/2022)

757809 (BUD: 5/18/2022)

Product: Cyclosporine OPHTH Oil Sol (Vet Use Only)

Variants: 0.1%, 0.2%, 2%, 5 mL, 10 mL

Model:

V-0060-2022

V-0061-2022

V-0062-2022

Lot Numbers:

750622 (BUD: 6/30/2022)

749299 (BUD: 6/30/2022)

754281 (BUD: 6/30/2022)

756306 (BUD: 6/30/2022)

757939 (BUD: 8/23/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89809

Status: Resolved

Manufacturer: Drug Depot, Inc., dba APS Pharmacy

Sold By: Drug Depot, Inc.; APS Pharmacy

Manufactured In: United States

Units Affected: 6 products (158 droptainers; 51 droptainers; 89 droptainers; 85 droptainers; 0; 0)

Distributed To: Nationwide

Agency Last Updated: April 1, 2022

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

Summary

What You Should Do

Check your pet's eye medication for Tacrolimus 0.03% (5 mL or 10 mL), Tacrolimus 0.02% (5 mL or 10 mL), or Cyclosporine 0.1%, 0.2%, or 2% (5 mL or 10 mL).

Look for the following lot numbers and Beyond Use Dates (BUD): 745456 (3/22/2022), 749007 (4/11/2022), 751293 (4/20/2022), 755647 (5/9/2022), 757809 (5/18/2022), 758301 (5/26/2022), 750622 (6/30/2022), 749299 (6/30/2022), 754281 (6/30/2022), 756306 (6/30/2022), or 757939 (8/23/2022).

If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact APS Pharmacy for further instructions.

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

Your Remedy Options

You have 2 options:

Option 1: Full Refund

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: Tacrolimus 0.03% OPHTH SOL (Vet Use Only)

Variants: 5 mL, 10 mL

Model:

V-0057-2022

V-0059-2022

Lot Numbers:

745456 (BUD: 3/22/2022)

749007 (BUD: 4/11/2022)

758301 (BUD: 5/26/2022)

Recall numbers V-0057-2022 and V-0059-2022 combined as variants of same concentration.

Product: Tacrolimus 0.02% OPHTH SOL (Vet Use Only)

Variants: 5 mL, 10 mL

Model:

V-0058-2022

Lot Numbers:

751293 (BUD: 4/20/2022)

755647 (BUD: 5/9/2022)

757809 (BUD: 5/18/2022)

Product: Cyclosporine OPHTH Oil Sol (Vet Use Only)

Variants: 0.1%, 0.2%, 2%, 5 mL, 10 mL

Model:

V-0060-2022

V-0061-2022

V-0062-2022

Lot Numbers:

750622 (BUD: 6/30/2022)

749299 (BUD: 6/30/2022)

754281 (BUD: 6/30/2022)

756306 (BUD: 6/30/2022)

757939 (BUD: 8/23/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89809

Status: Resolved

Manufacturer: Drug Depot, Inc., dba APS Pharmacy

Sold By: Drug Depot, Inc.; APS Pharmacy

Manufactured In: United States

Units Affected: 6 products (158 droptainers; 51 droptainers; 89 droptainers; 85 droptainers; 0; 0)

Distributed To: Nationwide

Agency Last Updated: April 1, 2022