|
|
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
|
|
|
TOPIC: Force Forever by GNMART INC: Recall - Due to Undeclared Drug Ingredients Diclofenac and Dexamethasone
AUDIENCE: Consumer, Health Care Professional, Pharmacy, Rheumatology, Cardiology
ISSUE: GNMART Inc. is recalling all lots of Force Forever for joint pain because FDA analysis has found product to contain undeclared diclofenac and dexamethasone. The affected product includes all lots and expiration date: 03/27/2030.
Risk Statement:
-
Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.
-
Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems.
The product was distributed nationwide via the internet at gnmart.com.
GNMart Inc. has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is used as a dietary supplement for joint pain.
RECOMMENDATIONS:
-
Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
-
Consumers that have product which is being recalled should stop using and return to place of purchase.
-
Consumers may return the products via mail to: GNMart, Inc., 15 Sawmill Ln, Dover Plains, NY 12522.
-
Consumers with questions regarding this recall can contact GNMart at info@gnmart.com by e-mail.
-
GNMart is notifying its customers by email and is arranging for return of all recalled products.
|
|
|
Health care professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
-
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
|
|
|
|
