Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID
Summary
The FDA issued a Class II for Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottle by Ecometics, Inc.. Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices..
Details
Source
Drug Recall
External ID
D-1096-2023
Action Date
2023-08-30
Status
Completed
Category
drug
Product Description
Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
Lot/Code Info: Lot: 9E098A
Quantity Affected: a) 9816 bottles; b) 10,776 bottles
Reason for Recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-09
Company
Norwalk, CT
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 51 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Ecometics, Inc. has 14 FDA actions in our database, including 14 recalls.
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 (Ecometics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ecometics, Inc. have FDA actions?
Ecometics, Inc. has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1096-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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