Compounding Pharmacy Asked by FDA to Recall Products

The FDA is warning health care professionals and patients about products intended to be sterile that were compounded by Medaus Inc.

The administration has formally requested that the compounding pharmacy, which is based in Birmingham, Alabama, recall products due to sterility concerns.

Administering nonsterile products that are supposed to be sterile may cause serious infections or death.

The FDA recommended that health care facilities check their supplies and quarantine products from Medaus that are intended to be sterile. The products were distributed both nationwide and internationally.

Many of the affected products are hormone replacement drugs, such as injectables and implantable pellets. Others are injectable nutritional products, such as vitamins, minerals, and amino acids.

“Patient safety is our top priority and patients deserve drugs that are made under safe conditions,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “We are deeply concerned about the safety of the products made by Medaus and the risks associated with them.”

During a March 2016 inspection at a Medaus facility, the FDA claimed that there were insanitary conditions, which could affect the sterility of drugs.

The FDA recommended on March 29, 2016, that the company recall all non-expired lots of drugs intended to be sterile, but the company refused.

On April 1, 2016, the FDA issued a formal statement advising against the use of “sterile” Medaus products.

Thus far, the FDA has not received reports of adverse events stemming from these products. Patients and health care professionals may report adverse reactions through the MedWatch Adverse Event Reporting program.