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MedWatch – The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Nature’s Wonderland Thyroid Formula by Penn Herb Company: Recall – Due to Possible Health Risk
AUDIENCE: Consumer, Patient, Rheumatology, Pharmacy
ISSUE: Penn Herb Company is recalling 51 bottles (60 Capsules per bottle) of Nature’s Wonderland Thyroid Formula (Item #: Sm32x, Lot #: 23289A), because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The recall was as the result of a routine sampling program by FDA which revealed that the finished products contained Salmonella. The company has ceased the production and distribution of the product as the company continues their investigation as to what caused the problem.
To date, no illnesses have been reported.
For more information about this recall, click on the red button “Read Recall“ below.
BACKGROUND: The recalled product is sold as a dietary supplement to treat thyroid.
RECOMMENDATIONS:
- Any consumer who has Nature’s Wonderland Thyroid Formula (Item #: Sm32x, Lot #: 23289A) should discontinue use immediately and are urged to return it to the place of purchase for a full refund.
- Consumers with questions may contact the company at 1-800-523-9971.
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Health professionals and patients 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.
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