Prescription Alternatives, Inc.: Tacrolimus and Cyclosporine Eye Drops Recalled for Lack of Sterility

Agency Publication Date: May 16, 2019

Summary

Prescription Alternatives, Inc. has recalled approximately 130 units of Tacrolimus and Cyclosporine ophthalmic (eye) drops dispensed to canine patients. These veterinary medications, including Tacrolimus Suspension (0.02% and 0.03%) and Cyclosporine 1% Drops, were found to have a lack of sterility assurance. Consumers should contact their veterinarian or the manufacturer immediately regarding these medications, which were dispensed between August and November 2018.

Risk

A lack of sterility assurance in eye medications means the products may contain microorganisms that could cause serious eye infections or other complications in animals. No specific injuries or infections have been reported in the data, but the contamination risk poses a moderate threat to pet health.

What You Should Do

Locate the prescription bottle and check the product name and lot code/date code on the label to see if it matches the affected batches.
For Tacrolimus Suspension 0.02% (10 mL), check for code 08152018:27.
For Tacrolimus Suspension 0.03% (10 mL), check for codes 09202018:31 or 10262018:08.
For Cyclosporine (A) Ophthalmic 1% Drops, check for codes 09072018:29, 10012018:93, 10052018:01, or 11012018:67.
Immediately stop using the affected eye drops on your pet and contact your veterinarian or pharmacist for guidance on alternative treatments.
Contact Prescription Alternatives, Inc. at 610 East Main Street, Frisco, Colorado, or by telephone for instructions on returning any unused product for a refund.
For additional questions, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

Your Remedy Options

Full Refund

Veterinary drug refund and guidance.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: TACROLIMUS SUSPENSION 0.02% OPHTHALMIC (10 mL)

Lot Numbers:

08152018:27

Product: TACROLIMUS SUSPENSION 0.03% OPHTHALMIC (10 mL)

Lot Numbers:

09202018:31

10262018:08

Product: CYCLOSPORINE (A) OPHTHALMIC 1% DROPS (10 mL)

Lot Numbers:

09072018:29

10012018:93

10052018:01

11012018:67

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81911

Status: Resolved

Manufacturer: Prescription Alternatives, Inc.

Sold By: Prescription Alternatives, Inc.

Manufactured In: United States

Units Affected: 3 products (10 mL; 20 mL; 100 mL)

Distributed To: Nationwide

Agency Last Updated: May 30, 2019

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

Risk

What You Should Do

Locate the prescription bottle and check the product name and lot code/date code on the label to see if it matches the affected batches.

For Tacrolimus Suspension 0.02% (10 mL), check for code 08152018:27.

For Tacrolimus Suspension 0.03% (10 mL), check for codes 09202018:31 or 10262018:08.

For Cyclosporine (A) Ophthalmic 1% Drops, check for codes 09072018:29, 10012018:93, 10052018:01, or 11012018:67.

Immediately stop using the affected eye drops on your pet and contact your veterinarian or pharmacist for guidance on alternative treatments.

Contact Prescription Alternatives, Inc. at 610 East Main Street, Frisco, Colorado, or by telephone for instructions on returning any unused product for a refund.

For additional questions, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.