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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall: T.R.U.E. Test Box Lot 94009

DATE RECALL INITIATED:

December 21, 2009

PRODUCT / LOT NUMBER / EXPIRATION DATE:

T.R.U.E. Test Box Lot #: 94009
T.R.U.E. Test Foil Panel Lot #’s: (Panel 1.1-A94195, Panel 2.1-B94009, Panel 3.1-C94009)
Expiration Date: December 10, 2010

MANUFACTURER:

Mekos Laboratories
Herredsvejen 2, Denmark

REASON:

This particular lot may contain an Ethylenediamine dihydrochloride patch #11 (Panel 1.1) that contains less than the labeled dose (0.018 mg of ethylenediamine per patch). Although within the required specification at product release from the manufacturer, internal extended commercial stability results at six (6) months indicate the possibility of a lesser amount in this particular patch. Customers who have product from the affected lot are asked to discontinue use immediately.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.