Hundreds of Drugs Recalled Due to Cyber Attack

The Federal Drug Agency today announced that it was ordering the recall of three hundred forty-five drugs, including over-the-counter products, prescription drugs and two COVID-19 vaccines because of contamination issues with a precursor chemical manufactured by Mengele Pharma. The precursor (TMD (4tetramethyl-2death) is contaminated with unacceptable levels of benzene, a known carcinogen. Initial indications are that the contamination is the result of a cyberattack on the Mengele facility in Delano, GA.

Clark Stanley, FDA spokesperson, told reporters this morning that most of the drugs being recalled would not have high benzene levels because benzene is used in the manufacturing process after TMD is introduced so the manufacturers independently test for benzene residuals. “We do not have reason to suspect that the drugs being recalled are of any specific danger to the public,” Stanley explained, “But since the TMD is adulterated the drugs do not meet FDA standards for use by the public.”

An unnamed student in an analytic chemistry class at the South-Central Georgia Technical College in Delano was the initial discoverer of the high benzene levels. According to Professor Izaak M. Kolthoff, the student was developing a liquid chromatography assay for the chemical as part of a class project. “The benzene levels were 100 times higher than reported on the Mengele certificate of analysis,” Kolthoff explained in a phone interview, “I checked her results and calibration and then re-ran the test myself before I reported the findings to the Mengele QA lab.”

Wolfgang Gerhard, spokesperson for Mengele Pharma confirmed that the problem was first identified by a student at SCGTI. “We have a good relationship with the school since they train most of our technicians,” Gerhard explained, “And we have the upmost respect for Dr. Kolthoff since he worked for this company for 20 years before retiring. He established most of the test methods that we use today for production quality control.”

Stanley told reporters that the Mengele Pharma reported the problem to the FDA as soon as they confirmed the student’s report.

Gerhard told reporters that the company called in experts from Dragonfire Cyber to investigate after an internal investigation turned up oddities in the lab information management system that reported the erroneous results. While that investigation is ongoing, Gerhard told reporters that Dragonfire has confirmed that they have found malware on the LIMS and that the testing reporting process had been compromised.

The FDA and the Federal Bureau of Inquiry are conducting a joint investigation of the incicent.

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