Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g)
Summary
The FDA issued a Class II for Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2 by Ecometics, Inc.. Reason: CGMP DEVIATIONS.
Details
Source
Drug Recall
External ID
D-0448-2023
Action Date
2023-03-15
Status
Terminated
Category
drug
Product Description
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Lot/Code Info: Lot # 2E116A, Exp. Date APR-24
Quantity Affected: 20,746 metal tubes/folding cartons
Reason for Recall
CGMP DEVIATIONS
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-24
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 126 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-0448-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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