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Medium RiskFDA Vet
Pets & Animals/Pet Medications

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy: Cyclosporine Ophthalmic Products Recalled for Lack of Sterility Assurance

Agency Publication Date: May 29, 2019
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Summary

Hiers Enterprises, LLC (Northwest Compounding Pharmacy) is recalling several compounded Cyclosporine ophthalmic (eye) drops and ointments due to a lack of sterility assurance. These products are intended for use in the eyes, and if they are not sterile, they could introduce bacteria or other contaminants directly into the eye. Approximately 58 units were distributed to medical facilities and individual patients, primarily in Oregon.

Risk

A lack of sterility in products applied to the eyes poses a significant risk of infection, which can lead to serious eye damage or vision loss. No specific injuries or infections have been reported in the provided data, but the potential for harm is high given the route of administration.

What You Should Do

  1. Check your medication container for the following lot numbers and expiration dates: Cyclosporine 2% drops (Lots 08172018@7 Exp 2/13/2019 or 10172018@32 Exp 3/2/2019), Cyclosporine 0.5% drops (Lot 07272018@2 Exp 1/23/2019), Cyclosporine 0.2% drops (Lot 10042018@10 Exp 3/2/2019), or Cyclosporine 2% ointment (Lot 09042018@16).
  2. Stop using these eye drops or ointments immediately to avoid the risk of infection.
  3. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects you may have experienced while using these products.
  4. Return any unused portions of the recalled products to the pharmacy for a refund and contact Northwest Compounding Pharmacy at 1350 Ne Stephens St Ste 42, Roseburg, Oregon, for further instructions.
  5. For additional questions, you can contact the FDA’s Center for Veterinary Medicine or the general FDA consumer complaint coordinator.

Your Remedy Options

💰Full Refund

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

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

Affected Products

Product: CYCLOSPORINE (A) IN OIL OPHTHALMIC DROPS 2% (5 mL and 10 mL)
Model:
V-0178-2019
Lot Numbers:
08172018@7 (Exp 2/13/2019)
10172018@32 (Exp 3/2/2019)
Date Ranges: exp 2/13/2019, exp 3/2/2019
Product: CYCLOSPORIN (A) IN OIL OPHTHALIC DROPS 0.5% (10 mL)
Model:
V-0179-2019
Lot Numbers:
07272018@2 (Exp 1/23/2019)
Date Ranges: exp 1/23/2019
Product: CYCLOSPORIN (A) IN OIL OPHTHALIC DROPS 0.2% (10 mL)
Model:
V-0180-2019
Lot Numbers:
10042018@10 (Exp 3/2/2019)
Date Ranges: exp 3/2/2019
Product: CYCLOSPORIN IN PETROLATUM 2% (5 mLs)
Model:
V-0181-2019
Lot Numbers:
09042018@16

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82720
Status: Resolved
Manufacturer: Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Sold By: Northwest Compounding Pharmacy; medical facilities; Physician's office
Manufactured In: United States
Units Affected: 4 products (1) Lot 08172018@7: Ten (10) 5 mL and Sixteen (16) 10mL bottles 2) 10172018@32: Ten (10) 5 mL bottles and Nineteen (19) 10 mL bottles; 1 - 10 mL bottle; 1 - 10 mL bottle; 5 mL)
Distributed To: Oregon
Agency Last Updated: June 4, 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