FDA Expands Nationwide Recall of Supplements “Tainted With Drug Ingredients”
Kmpzzz / Shutterstock
RELATED: Common Anxiety Medication Recalled Over “Life-Threatening” Mistake, FDA Says .
The Umary supplement recall was initiated after FDA laboratory analysis confirmed that the products were “tainted with the drug ingredients” diclofenac and omeprazole.
U.S. FDA
“Products containing diclofenac and omeprazole cannot be marketed as dietary supplements,” the July 22 FDA notice states. “Umary is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.”
According to the FDA, omeprazole is a proton pump inhibitor (PPI) that is used to treat stomach acid-related disorders. The drug can cause different conditions, including “serious skin reactions, abdominal pain, diarrhea, nausea, and headache,” the notice states.
“This hidden ingredient may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications,” the FDA adds.
RELATED: Supplements Sold Nationwide Recalled Over Potentially Severe “Adverse Events.”
Diclofenac, on the other hand, belongs to the class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).
“There is a reasonable probability that consumption of high levels of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses,” the FDA warns.
If you have taken these supplements and experienced any problems that may be related to use, the FDA advises you to contact your healthcare provider or physician. Adverse events should also be reported to the FDA’s MedWatch Adverse Event Reporting program online or via regular mail or fax.
Consumer questions can be posed to Main Products, Inc. directly at [email protected] . The company will respond to emails within 24 to 48 hours, the FDA notice states.
We offer the most up-to-date information from top experts, new research, and health agencies, but our content is not meant to be a substitute for professional guidance. When it comes to the medication you’re taking or any other health questions you have, always consult your healthcare provider directly.
- Source: U.S. FDA: Dietary Supplements
- Source: U.S. FDA: SoloVital.com Issues Voluntary Nationwide Recall of Umary Acido Hialuronica, Suplemento Alimenticio 850 mg Capsules Due to the Presence of Undeclared Drug Ingredients: Diclofenac and Omeprazole
- Source: U.S. FDA: Main Products, Inc. Issues Voluntary Nationwide Recall of Umary Acido Hialuronico, Suplemento Alimenticio Due to the Presence of Undeclared Drug Ingredients: Diclofenac and Omeprazole
- Source: Reporting Serious Problems to FDA
