NOVEMBER 5, 2013 – Specialty Enzymes & Biotechnologies announced last month a voluntary recall of specific lots of enzyme product because they have the potential to be contaminated with trace amounts of the antibiotic chloramphenicol. These lots represent a very small fraction of annual production. All customers affected by this recall have already been notified.
Specialty Enzymes consulted a leading scientific firm to evaluate health risk, no matter how remote. Based on a comprehensive scientific analysis, the firm determined that in this case, the probability of a serious adverse health consequence is remote. Though unlikely, any other potential consequences would be temporary or medically reversible. As a precautionary measure, Specialty Enzymes conducted a voluntary recall of the specific lot numbers affected by this issue.
For nearly 30 years, Specialty Enzymes has distributed high-quality enzyme solutions to customers throughout the nation and the world. This is the first time the company has ever issued a product recall. We do not use chloramphenicol in the manufacture of our products. Rather, the issue is believed to originate with certain raw materials used by Specialty Enzymes in the manufacture of its product. We deeply apologize for any inconvenience caused to our customers, and have taken comprehensive measures to quickly and effectively address the issue.
Moving forward, Specialty Enzymes is conducting rigorous multi-level testing of all products. This includes independent third-party laboratory testing before raw materials are sent to Specialty Enzymes and re-testing of the same materials prior to acceptance in our facilities. As an added precautionary measure, we are also testing our finished products before they are shipped to our customers. Finally, we have engaged a reputable independent consultant to conduct a root cause and corrective action analysis at the supplier’s facility. Specialty Enzymes remains committed to consumer safety, quality products and customer satisfaction.
Specialty Enzymes is working closely with the FDA and other regulatory bodies to bring a swift and thorough resolution to this matter. Please do not hesitate to contact us with any questions.