Recall -- Firm Press Release
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ION Labs Inc. Recalls Influend Cough and Cold Products, in Alabama, Because Of Possible Health Risk
FOR IMMEDIATE RELEASE -- Clearwater, Fl. – April 13, 2009 --- ION Labs Inc. of Clearwater, FL. is voluntarily recalling all of the Influend Cough and Cold products sold on or after May 30, 2008. ION Labs Inc. is Recalling the listed products due to the products not tested in conformance with the specifications of the lab, therefore the products may have a possibility to be super potent. Possible complications may include Tachycardia, palpitations, arrhythmias, cardiovascular collapse with hypotension, headaches, dizziness, anxiety, restlessness and nervousness. The following products were distributed and sold directly to consumers in the Madison/Huntsville, Alabama area:
- 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
While no illnesses have been reported to date, ION Labs, Inc. has ceased distribution of these products until further notice.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.
ION Labs, Inc.
115th Ave. N.
Clearwater, Fl. 33760
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at the MedWatch website at www.fda.gov/medwatch
Consumers who have questions about the above recall may contact ION Labs Customer Service at 1-877-990-4466 and ask for the Quality Director at Ext. (212). Hours of operation are M-F from 8 a.m. to 5 p.m. EDT.