Red Mountain Compounding Pharmacy Ophthalmic Medications Recalled

Agency Publication Date: November 6, 2021

Summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, has recalled 11 different compounded eye medications (ophthalmic products) used for veterinary patients. The recall was initiated because an FDA inspection raised concerns about the pharmacy's ability to ensure the sterility of these medications. The recall includes various strengths of Cyclosporine, Tacrolimus, and Acetylcysteine in ointment, solution, and suspension forms distributed to patients in Arizona.

Risk

Using a non-sterile medication intended for the eye can lead to serious eye infections, which may cause pain, vision loss, or other permanent damage. While no injuries have been reported, the lack of sterility assurance means the products may contain harmful bacteria or fungi.

What You Should Do

Check your medication containers for the following names: Red Mountain Compounding Rx S-CYCLOSPORINE/TACROLIMUS, S-TACROLIMUS, S-ACETYLCYSTEINE, S-CYCLOSPORINE, or S-Tacrolimus. See the Affected Products section below for the full list of affected codes.
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 the manufacturer or supplier for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

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: Red Mountain Compounding Rx S-CYCLOSPORINE/TACROLIMUS 2/0.02% IN MCT OIL OPTH (10 ML)

Variants: 2/0.02%, 10 ML

Model:

V-0012-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.02% OPTH OINT (VET) (5GM)

Variants: 0.02%, 5GM

Model:

V-0013-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.03% OPTH OINT (VET) (5GM)

Variants: 0.03%, 5GM

Model:

V-0014-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-ACETYLCYSTEINE 2% OPTH SOLN

Variants: 2%

Model:

V-0015-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.02% IN MCT OIL OPTH (15 ML)

Variants: 0.02%, 15 ML

Model:

V-0016-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.03% IN MCT OIL OPTH (15 ML)

Variants: 0.03%, 15 ML

Model:

V-0017-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.03% AQUEOUS OPTH SUSP (10 ML)

Variants: 0.03%, 10 ML

Model:

V-0018-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-CYCLOSPORINE 2% IN MCT OIL OPTH (15 ML)

Variants: 2%, 15 ML

Model:

V-0019-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx S-CYCLOSPORINE 0.2% OPTH OINT (VET) (5 GM)

Variants: 0.2%, 5 GM

Model:

V-0020-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx S-CYCLOSPORINE 1% IN MCT OIL OPTH (15 ML)

Variants: 1%, 15 ML

Model:

V-0021-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx S-Tacrolimus 0.01% IN MCT OIL OPTH (15 ML)

Variants: 0.01%, 15 ML

Model:

V-0022-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88697

Status: Resolved

Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Sold By: Red Mountain Compounding Pharmacy

Manufactured In: United States

Distributed To: Arizona

Agency Last Updated: November 18, 2021

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 medication containers for the following names: Red Mountain Compounding Rx S-CYCLOSPORINE/TACROLIMUS, S-TACROLIMUS, S-ACETYLCYSTEINE, S-CYCLOSPORINE, or S-Tacrolimus. See the Affected Products section below for the full list of affected codes.

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 the manufacturer or supplier for further instructions.

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

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: Red Mountain Compounding Rx S-CYCLOSPORINE/TACROLIMUS 2/0.02% IN MCT OIL OPTH (10 ML)

Variants: 2/0.02%, 10 ML

Model:

V-0012-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.02% OPTH OINT (VET) (5GM)

Variants: 0.02%, 5GM

Model:

V-0013-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.03% OPTH OINT (VET) (5GM)

Variants: 0.03%, 5GM

Model:

V-0014-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-ACETYLCYSTEINE 2% OPTH SOLN

Variants: 2%

Model:

V-0015-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.02% IN MCT OIL OPTH (15 ML)

Variants: 0.02%, 15 ML

Model:

V-0016-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.03% IN MCT OIL OPTH (15 ML)

Variants: 0.03%, 15 ML

Model:

V-0017-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-TACROLIMUS 0.03% AQUEOUS OPTH SUSP (10 ML)

Variants: 0.03%, 10 ML

Model:

V-0018-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx, S-CYCLOSPORINE 2% IN MCT OIL OPTH (15 ML)

Variants: 2%, 15 ML

Model:

V-0019-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx S-CYCLOSPORINE 0.2% OPTH OINT (VET) (5 GM)

Variants: 0.2%, 5 GM

Model:

V-0020-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx S-CYCLOSPORINE 1% IN MCT OIL OPTH (15 ML)

Variants: 1%, 15 ML

Model:

V-0021-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only

Product: Red Mountain Compounding Rx S-Tacrolimus 0.01% IN MCT OIL OPTH (15 ML)

Variants: 0.01%, 15 ML

Model:

V-0022-2022

Lot Numbers:

All lots within expiry

For Ophthalmic Use Only