Chester Labs
This article was originally published in The Tan Sheet
Executive Summary
Recall initiated by System TLC mouth rinse (4 oz., product #535-4) marketer and manufacturer Medical Packaging Technologies in voluntary action March 2. One lot of the product (#0049001) is being recalled for contamination with Burkholderia cepacia. "Infections from these bacteria are difficult to treat, and can be associated with high morbidity and mortality rates," the company said. Several other lots of System TLC also were recalled "because they do not meet the manufacturer's specifications," Cincinnati-based Chester added. Details of the recall and directions to distributors and retailers for compliance are available through FDA's MedWatch Web site
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