Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Summary
The FDA issued a Class II for Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpar by Prescription Labs Inc dba Greenpark. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0804-2021
Action Date
2021-09-22
Status
Terminated
Category
drug
Product Description
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Lot/Code Info: Lots: 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
Quantity Affected: 350 bottles
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-18
Company
Houston, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Prescription Labs Inc dba Greenpark) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Prescription Labs Inc dba Greenpark have FDA actions?
This is the only FDA action we have on record for Prescription Labs Inc dba Greenpark in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0804-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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