|
Multi-Mex Distributor Inc. Dietary Supplements: Recall - Product Packaging Mimics OTC Antibiotics
AUDIENCE: Consumer, PediatricsISSUE: Multi-Mex Distributor, Inc., recalled dietary supplements that may be labeled as antibiotic drugs. The recall was initiated after an FDA inspection revealed the product packaging mimics antibiotics readily available in Mexico and possibly familiar to Hispanic consumers.
The products were distributed in the following states: Georgia, Tennessee, California, Illinois, Texas, North Carolina, South Carolina, Colorado, and Indianapolis, to the retail store and distributors.
BACKGROUND: Warnings of these dietary supplements made news in Texas on Thursday, April 28th, when four children were taken to a Medical Center due to worsening illnesses after being given dietary supplements the parents may have believed were antibiotics and which were packaged to resemble antibiotics that are readily available as over the counter drugs in Mexico. Giving the dietary supplement delayed legitimate medical treatment. Although the labels were printed in English and Spanish, the packaging appears to be an intentional marketing ploy to mimic antibiotics and directed at Hispanic buyers. It was determined the children had been given a dietary supplement, Amoxilina, which the parents may have believed was the antibiotic Amoxicillin.
RECOMMENDATION: Consumers who have purchased any of the above listed products are urged to return it to the place of purchase for a full refund. Retail stores and distributors are to return the products to Multi-Mex. See the Press Release for listing of recalled products.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems 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: 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
Read the MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm254708.htm
Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=05_10_2011_0915&cpp[type]=S
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
