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Medium RiskFDA Vet
Pets & Animals/Pet Medications

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy: Various Compounded Veterinary Medications Recalled for Lack of Processing Controls

Agency Publication Date: October 21, 2019
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Summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling approximately 51 units of various compounded veterinary medications, including eye drops, injections, and ointments. These medications, which include cyclosporine, desmopressin, edetate disodium, prednisolone, and tacrolimus, are being recalled due to a lack of processing controls that may affect the quality and safety of the products. These veterinary products were distributed specifically in Arizona between May and August 2019.

Risk

A lack of processing controls in a compounding environment can lead to products that are not sterile or do not contain the correct amount of medication, potentially causing infections or ineffective treatment for pets. No specific injuries or adverse events have been reported in the provided data.

What You Should Do

  1. Check your pet's medication labels for the following specific lot numbers and expiration dates: Cyclosporine (Lots S06182019DH@09, S06182019DH@07, S06252019DH@18, S06252019DT@03, S06272019DT@04, S06112019DH@15, S07022019DH@04); Desmopressin (Lots S05212019DH@19, S08022019DH@04); Edetate Disodium (Lot S08012019DH@05); Prednisolone (Lots S05212019DT@04, S06182019DT@01); and Tacrolimus (various lots including S07162019DH@04, S07222019DH@03, and others).
  2. Immediately stop using the recalled medication on your pet and consult with your veterinarian or pharmacist to discuss alternative treatment options.
  3. Return any unused portions of the medication to Red Mountain Compounding Pharmacy for a refund and further guidance on safe disposal.
  4. Contact Red Mountain Compounding Pharmacy directly at their Mesa, Arizona location or call your healthcare provider if your pet shows signs of an adverse reaction.
  5. For additional questions regarding this recall, contact the FDA Consumer Complaint Coordinator at 1-888-463-6332.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider or pharmacist and return for refund.

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

Affected Products

Product: S-CYCLOSPORIN 0.02% CORN OIL OPTH SUSP; S-CYCLOSPORINE 1% OPTH IN MCT OIL; S-CYCLOSPORINE 1%/CORN OIL OPTH SUSP; S-CYCLOSPORINE 2% OPTH CORN OIL SUSP
Lot Numbers:
S06182019DH@09 (Exp 9/18/19)
S06182019DH@07 (Exp 9/18/19)
S06252019DH@18 (Exp 9/25/19)
S06252019DT@03 (Exp 9/25/19)
S06272019DT@04 (Exp 9/27/19)
S06112019DH@15 (Exp 9/11/19)
S07022019DH@04 (Exp 10/2/19)
Date Ranges: Exp 9/18/19, Exp 9/25/19, Exp 9/27/19, Exp 9/11/19, Exp 10/2/19
Product: S-DESMOSPRESSIN 25MCG/ML INJ SOLN
Lot Numbers:
S05212019DH@19 (Exp 8/21/19)
S08022019DH@04 (Exp 11/2/19)
Date Ranges: Exp 8/21/19, Exp 11/2/19
Product: S-EDETATE DISOD. 1% OPTH SOLN
Lot Numbers:
S08012019DH@05 (Exp 8/15/19)
Date Ranges: Exp 8/15/19
Product: S-PREDNISOLONE ACET 1% OPTH DROPS
Lot Numbers:
S05212019DT@04 (Exp 8/21/19)
S06182019DT@01 (Exp 9/18/18)
Date Ranges: Exp 8/21/19, Exp 9/18/18
Product: S-TACROLIMUS 0.02% CORN OIL OPTH; S-TACROLIMUS 0.02% OLIVE OIL OPTH; S-TACROLIMUS 0.03% AQUEOUS SUSP; S-TACROLIMUS 0.03% CORN OIL OPTH; S-TACROLIMUS 0.03% OPTH OINT (VET); S-TACROLIMUS 0.1% CORN OIL OPTH
Lot Numbers:
S07162019DH@04 (Exp 10/16/19)
S07222019DH@03 (Exp 10/22/19)
S06112019DH@21 (Exp 9/11/19)
S07032019DT@08 (Exp 10/3/19)
s05162019dt@14 (Exp 8/16/19)
S05232019DH@14 (Exp 8/23/19)
S06302019DH@02 (Exp 9/30/19)
S07242019DH@06 (Exp 10/24/19)
S05082019DT@03 (Exp 8/8/19)
S05132019DH@04 (Exp 8/13/19)
S05302019DT@07 (Exp 8/30/19)
S05312019DT@04 (Exp 8/31/19)
S07102019DT@01 (Exp 10/10/19)
S07162019DH@06 (Exp 10/16/19)
S07232019DH@15 (Exp 10/23/19)
S06252019DT@04 (Exp 9/25/19)
S07022019DT@06 (Exp 10/2/19)
Date Ranges: Exp 10/16/19, Exp 10/22/19, Exp 9/11/19, Exp 10/3/19, Exp 8/16/19, Exp 8/23/19, Exp 9/30/19, Exp 10/24/19, Exp 8/8/19, Exp 8/13/19, Exp 8/30/19, Exp 8/31/19, Exp 10/10/19, Exp 10/23/19, Exp 9/25/19, Exp 10/2/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83708
Status: Resolved
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Sold By: Red Mountain Compounding Pharmacy
Manufactured In: United States
Units Affected: 5 products (10 droptainers; 2 vials; 1 droptainer; 2 droptainers; 36 units)
Distributed To: Arizona
Agency Last Updated: October 23, 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.

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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 ยท Raw API Response