The U.S. Food & Drug Administration (FDA) announced this week that ION Labs Inc. of Clearwater, Fla., has issued a voluntary recall of all Influend Cough and Cold products in Alabama, sold on or after May 30, 2008. The recalled products did not meet proper testing specifications and may have a possibility to be super-potent, posing possible health risks.

Health risks from the recalled products may include heart problems such as tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypertension, as well as headaches, dizziness, anxiety, restlessness, and nervousness.

The recall involves the following products:

  • Influend Cold and Cough, 24 tablets, product code / lot #800074
  • Influend Severe Cold & Flu, 24 tablets, product code / lot #800075
  • Influend JR Cold & Cough, 4 oz. bottle, product code / lot #800076
  • Influend JR Severe Cold & Flu, 4 oz. bottle, product code / lot #800077

No illnesses have been reported to date, but ION Labs, Inc. has stopped distribution of these products until further notice, and consumers who have these products in their possession are advised to stop use immediately and contact their physician if they have experienced any health problems that may be related to this medication.

The FDA asks consumers to report any adverse events that may be related to the use of this product to the FDA MedWatch program by calling 1-800-FDA-1088 or online at the MedWatch web site at www.fda.gov/medwatch.

Questions may be directed to ION Labs Customer Service department by calling 1-877-990-4466, ext. 212, between 8 a.m.-5 p.m. EDT, Monday through Friday.

Customers can return the product for a full refund by mailing to:

ION Labs, Inc.
115th Ave. N.
Clearwater, FL 33760

SOURCE: http://www.fda.gov/oc/po/firmrecalls/ionlabs04_09.html



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