Medications & Supplements/Prescription Drugs

Greenpark Spironolactone Ophthalmic Solution Recalled for Sterility Risk

Agency Publication Date: September 16, 2021

Summary

Prescription Labs Inc (dba Greenpark) is recalling 350 bottles of Spironolactone Ophthalmic Solution (spironolactone), dispensed in 15 mL bottles from Greenpark Compounding Pharmacy. This prescription eye medication is being recalled because there is no assurance that the product is sterile. Using non-sterile eye drops can introduce bacteria or other contaminants directly into the eye, potentially causing serious infections.

Risk

Non-sterile ophthalmic solutions pose a risk of eye infections. While no incidents or injuries have been reported to date, a lack of sterility assurance means the solution could be contaminated, which can lead to vision-threatening complications or systemic illness.

What You Should Do

This recall affects Greenpark Compounding Pharmacy Spironolactone Ophthalmic Solution (0.005 mg/mL) sold in 15 mL bottles labeled as Rx only.
Check the lot number printed on your prescription bottle. The affected lot numbers are: 03012021@35, 04132021@10, 05102021@12, 06012021@28, 07012021@25, 03012021@36, 04132021@12, 05102021@11, 06012021@29, 07132021@14, 03152021@9, 06162021@21, 07132021@16, 03152021@10, and 06162021@22.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Spironolactone Ophthalmic Solutionby Greenpark Compounding Pharmacy

Variants: 0.005 mg/mL, 15 mL bottles, Rx only

Lot Numbers:

03012021@35

04132021@10

05102021@12

06012021@28

07012021@25

03012021@36

04132021@12

05102021@11

06012021@29

07132021@14

03152021@9

06162021@21

07132021@16

03152021@10

06162021@22

Dispensed by Greenpark Compounding Pharmacy.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88515

Status: Resolved

Manufacturer: Prescription Labs Inc dba Greenpark

Sold By: Greenpark Compounding Pharmacy

Manufactured In: United States

Units Affected: 350 bottles

Distributed To: Nationwide

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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Greenpark Compounding Pharmacy Spironolactone Ophthalmic Solution (0.005 mg/mL) sold in 15 mL bottles labeled as Rx only.

Check the lot number printed on your prescription bottle. The affected lot numbers are: 03012021@35, 04132021@10, 05102021@12, 06012021@28, 07012021@25, 03012021@36, 04132021@12, 05102021@11, 06012021@29, 07132021@14, 03152021@9, 06162021@21, 07132021@16, 03152021@10, and 06162021@22.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Spironolactone Ophthalmic Solutionby Greenpark Compounding Pharmacy

Variants: 0.005 mg/mL, 15 mL bottles, Rx only

Lot Numbers:

03012021@35

04132021@10

05102021@12

06012021@28

07012021@25

03012021@36

04132021@12

05102021@11

06012021@29

07132021@14

03152021@9

06162021@21

07132021@16

03152021@10

06162021@22

Dispensed by Greenpark Compounding Pharmacy.