Ranier's Compounding Laboratory: Sterile Ophthalmic Drops Recalled for Potential Contamination Risk

Agency Publication Date: August 15, 2018

Summary

Ranier's Compounding Laboratory is recalling various 0.03% Tacrolimus and 1% Cyclosporine ophthalmic (eye) drops because manufacturing practices at the firm may have compromised the sterility of the products. Approximately 25 units were distributed, which are intended to be sterile; however, a potential contamination risk exists that could lead to serious eye infections. These prescription medications were dispensed in 5 mL and 10 mL droptainers exclusively in Pennsylvania.

Risk

The use of contaminated eye drops poses a risk of serious eye infections, which can lead to vision loss or other severe health complications. While no specific incidents have been reported, the firm's practices were found to pose a significant risk to the sterile environment required for these medications.

What You Should Do

Check your medication bottles for 0.03% Tacrolimus Ophthalmic drops (5 mL droptainer) with lot numbers 062218-1 (expiring 8/21/2018) or 070318-3 (expiring 9/01/2018).
Check your medication bottles for 1% Cyclosporine Ophthalmic drops (5 mL or 10 mL droptainers) with lot numbers 070218-2 (expiring 8/31/2018) or 070218-3 (expiring 8/31/2018).
Contact your healthcare provider or veterinarian (if prescribed for a pet) immediately for guidance on whether to continue or stop using the medication.
Return any unused product to Ranier's Compounding Laboratory at 1107 Lowry Ave, Jeannette, Pennsylvania, 15644-3030 for a refund.
Contact your pharmacist at Ranier's Compounding Laboratory to discuss concerns and obtain further instructions regarding replacement therapy.
For additional questions, contact the FDA Veterinary Medicine hotline at 1-240-402-7002.

Your Remedy Options

Full Refund

Pharmaceutical refund

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

Affected Products

Product: 0.03% Tacrolimus Ophthalmic drops (10 mL)

Model:

V-0281-2018

Lot Numbers:

062218-1 (Exp 8/21/2018)

070318-3 (Exp 9/01/2018)

Date Ranges: 8/21/2018, 9/01/2018

Product: 1 % Cyclosporine Ophthalmic drops (15 mL)

Model:

V-0282-2018

Lot Numbers:

070218-2 (Exp 8/31/2018)

070218-3 (Exp 08/31/2018)

Date Ranges: 8/31/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80792

Status: Resolved

Manufacturer: Ranier's Compounding Laboratory

Sold By: Ranier's Compounding Laboratory

Manufactured In: United States

Units Affected: 2 products (10 mL; 15 mL)

Distributed To: Pennsylvania

Agency Last Updated: August 27, 2018

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

Check your medication bottles for 0.03% Tacrolimus Ophthalmic drops (5 mL droptainer) with lot numbers 062218-1 (expiring 8/21/2018) or 070318-3 (expiring 9/01/2018).

Check your medication bottles for 1% Cyclosporine Ophthalmic drops (5 mL or 10 mL droptainers) with lot numbers 070218-2 (expiring 8/31/2018) or 070218-3 (expiring 8/31/2018).

Contact your healthcare provider or veterinarian (if prescribed for a pet) immediately for guidance on whether to continue or stop using the medication.

Return any unused product to Ranier's Compounding Laboratory at 1107 Lowry Ave, Jeannette, Pennsylvania, 15644-3030 for a refund.

Contact your pharmacist at Ranier's Compounding Laboratory to discuss concerns and obtain further instructions regarding replacement therapy.

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

Affected Products

Product: 0.03% Tacrolimus Ophthalmic drops (10 mL)

Model:

V-0281-2018

Lot Numbers:

062218-1 (Exp 8/21/2018)

070318-3 (Exp 9/01/2018)

Date Ranges: 8/21/2018, 9/01/2018

Product: 1 % Cyclosporine Ophthalmic drops (15 mL)

Model:

V-0282-2018

Lot Numbers:

070218-2 (Exp 8/31/2018)

070218-3 (Exp 08/31/2018)

Date Ranges: 8/31/2018