Alabama Compounder Recalls Nonexpired Drugs, Stops Production of Sterile Compounds

An Alabama compounder is recalling all of its nonexpired drug products over possible contamination issues and stopped production of sterile compounds after the FDA received reports of adverse events.

The recall affects drugs distributed by Medistat RX of Foley, Ala., between Nov. 1, 2014, and Sept. 3. FDA investigators and Alabama state inspectors observed deficiencies during a recent inspection that raised concerns about Medistat’s ability to assure the sterility of its products, the agency says.

Previously, the FDA conducted a series of inspections from Sept. 9 to Sept. 18, 2014, that resulted in a Form 483. In it, the FDA dinged the company for:

• Distributing two lots of progesterone that failed potency tests;
• Not testing each batch of drugs for potency;
• Having deficient complaint procedures that didn’t allow for review to determine if complaints required reporting to the FDA;
• Allowing employees to wear nonsterile face masks while producing sterile drug products; and
• Not calibrating incubator thermometers.

The recall is the latest in a string of FDA and industry actions related to sterility issues at drug compounding facilities. In June, the FDA issued a warning letter to a California compounder and Form 483s to two Tennessee compounders. The warning letter was the 19th issued to a drug compounder for sterility problems this year.

Medistat is registered with the FDA as an outsourcing facility, requiring it to comply with current good manufacturing practices. A Medistat spokeswoman says the company is working with agency and Alabama investigators to solve their concerns and resume operations.

It is critical for drugmakers to ensure that quality controls will keep products from being at risk. Order our report The New Excipient GMP Standard: A Guide for Drugmakers for a detailed introductory tour of the 363 standard!