Unique Pharmaceuticals halts sterile drug production after FDA's 'formal' request

FDA warns hospitals that Texas compounder's products are unsafe

Unique Pharmaceuticals halts sterile drug production after FDA's 'formal' request

July 24, 2014 | By Eric Palmer

 

 

Most companies voluntarily recall products, and sometimes even stop production, when they or the FDA find quality issues. In the case of a Texas compounder, the FDA has formally requested that it halt sterile drug work and pull back all of its sterile products, including N-Acetyl Cysteine 20%. The FDA also warned healthcare providers that had bought sterile drugs from the Temple, TX-based Unique Pharmaceuticals to immediately quarantine them because they may be contaminated and could harm patients. The agency said problems at the compounder were uncovered during two recent inspections which found unsanitary conditions. In 2012, drugs tied to a Massachusetts compounding company were tied to a bacterial meningitis outbreak that sickened hundreds of people and killed more than 60. Notice | More