Recalls for 05/06/2014

Alere Initiates Voluntary URGENT PRODUCT RECALL of Alere INRatio 2 PT/INR Professional Test Strips
05/06/2014 Food Recall

WALTHAM, Mass. – Alere Inc. (NYSE:ALR) has initiated a voluntary Class 1 recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). This action is a result of complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

  • Company:
    Alere Inc.
  • Problem
    significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test.
Eugene Oregon, Inc. Issues Voluntary Nationwide Recall of African Black Ant, Black Ant, and Mojo Risen Dietary Supplements Which May Contain Undeclared Active Pharmaceutical Ingredients
05/06/2014 Food Recall

Eugene Oregon, Inc. is voluntarily conducting this recall because FDA analysis of these products distributed to a third party revealed that the distributed products contained undeclared amounts of the active pharmaceutical ingredients sildenafil and tadalafil—FDA-approved pharmaceutical ingredients used to treat erectile dysfunction. Conclusive testing has not been done to confirm that the recalled products do, in fact, contain sildenafil and/or tadalafil and this recall is being executed as a precautionary measure.

  • Company:
    Eugene Oregon, Inc.
  • Problem
    Unapproved New Drugs – Products May Contain Sildenafil And Tadalafil
Slim Trim U: Public Notification - Undeclared Drug Ingredient
05/06/2014 Medical Recall

Risk of increased blood pressure and/or pulse rate.

  • Category
    Heart
Natural Body Solution: Public Notification - Undeclared Drug Ingredient
05/06/2014 Medical Recall

Risk of increased blood pressure and/or pulse rate.

  • Category
    Heart
Pacific Organic Produce Announce Voluntary Recall of Mangos Due to Possible Health Risk
05/06/2014 Food Recall

Pacific Organic Produce, San Francisco, CA is voluntarily recalling a limited number of cases of organic Tommy Atkins mangos (PLU numbers 94051 & 94959) that were sold under the Purity Organic brand between the dates of April 14, 2014 and May 2, 2014 due to a possible health risk from Listeria monocytogenes.

  • Company:
    Pacific Organic Produce
  • Problem
    Listeria Monocytogenes