In today’s world, doctors and patients alike rely on new types of drugs to help manage a variety of illnesses. Some of the most popular are liquid drugs, which are much easier for children, older adults, and others who may have trouble taking other types of medications. While most liquid drugs have been proven to be safe and effective, a recent recall by the U.S. Food and Drug Administration has focused on liquid drugs manufactured by Davie, FL company PharmaTech. With its recall, the FDA has advised healthcare professionals as well as patients to not use any PharmaTech liquid drugs. In addition to this, the agency is also directing those who have purchased any of these products to have them quarantined, and to then contact the local FDA pharmaceutical recall coordinator for additional information on how to proceed.
Since this recall has affected multiple distributors across the United States, the FDA has focused on ensuring all associated distributors are made aware of the potential problems linked with the PharmaTech liquid drugs. Beginning on August 2nd, Rugby Laboratories recalled two PharmaTech liquid drugs, Diocto Liquid and Diocto Syrup, due to possible bacterial contamination. According to FDA reports, adverse events have been reported regarding the use of these drugs, most notably patient infections. In addition to Rugby, additional distributors Leader Brand and Major Pharmaceuticals have also been named by the FDA as those where PharmaTech liquid drugs may have been distributed.
While many people assume it will be an easy process to determine which liquid drugs came from PharmaTech, that may not be the case. According to the FDA, the majority of these products do not have PharmaTech labels, making it extremely difficult for pharmacies and healthcare professionals to determine their origin. To ensure the process goes as smoothly as possible, the FDA has recommended all pharmacies check with their supplier to determine the proper manufacturer.
In 2016, the Centers for Disease Control conducted an investigation into these liquid drugs and came to a number of conclusions. Perhaps most important of all was the finding that the same bacterium found in other liquid drugs was also found in the group of liquid drugs from PharmaTech. Because of this, the FDA in October 2016 issued a warning to healthcare professionals, urging them to not use any types of oral liquid docusate sodium manufactured by PharmaTech. Following this warning, the FDA stated it would continue monitoring the situation, and would closely examine any reports of adverse reactions.
Even though the recall for PharmaTech liquid drugs has been in place for nearly one year, there are still many questions being asked by those with knowledge of the situation. One of the most-asked questions centers around why distributors were still able to gain access to PharmaTech oral liquid drugs after the CDC investigation and recall had occurred over one year ago. To answer this question, the FDA noted that any recalls were considered to be voluntary, and it does not have recall authority over drug products. Along with statements from the FDA, Major Pharmaceuticals declined to comment on the matter, while Rugby Laboratories has not responded to requests for comments.
While the recall remains in place, the FDA continues to closely monitor the situation regarding PharmaTech liquid drugs. With pharmacies continuing to check with their suppliers to determine if any PharmaTech liquid drugs are still in their possession, it’s clear all healthcare professionals will still need to be very diligent to ensure the safety of their patients. In doing so, all contaminated drugs should be discovered.
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