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.
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.
Risk of increased blood pressure and/or pulse rate.
Risk of increased blood pressure and/or pulse rate.
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.