ISSUE: IQ Formulations, of Sunrise, Florida is initiating a recall of all lots of its 45-capsule bottles of Hydravax due to potential inclusion of an unlisted ingredient. The FDA has advised IQ Formulations that an analysis of a sample from one lot of Hydravax (Lot # 2458, Exp # 07/16) revealed the presence of an undeclared ingredient – a diuretic. Diuretics are prescription drugs and thus, are not listed on the packaging label for Hydravax. Consumers are hereby notified not to use the product.
Possible effects of using a diuretic include an electrolyte imbalance due to water loss. Symptoms include: polyuria, nausea, vomiting, weakness, lassitude, fever, flushed face, and hyperactive deep tendon reflexes. Fluid and electrolyte imbalances are the most important concern. Excessive doses of diuretics may elicit hyperkalemia, dehydration, nausea, vomiting and weakness and possibly hypotension. Overdosing with a diuretic has been associated with hypokalemia, hypochloremia, hyponatremia, dehydration, lethargy and gastrointestinal irritation. People experiencing these problems should seek immediate medical attention.
BACKGROUND: The product comes in a 45 capsule bottle. The recalled Hydravax was distributed nationwide in retail stores and mail order. Production of the product has been suspended while the company continues their investigation as to the source of the potential unlisted ingredient.
RECOMMENDATION: All consumers who have purchased HYDRAVAX 45 capsule bottles are urged to return them to the place of purchase for a full refund. Consumers and distributors with questions regarding this recall should contact IQ Formulations Customer Service at Recall@iqformulations.com or by phone at 800-626-1022 from Monday through Friday from 9 am to 5 pm EST.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
[11/29/2013 - Firm Press Release - IQ Formulations]