Pharmaceutical

Compounding pharmacy recalls products due to mold contamination

mold in compounded drugs Compounding pharmacy recalls products due to mold contaminationMed Prep Consulting, Inc., a compounding pharmacy based in Tinton Falls, NJ, is recalling all products after mold was discovered floating in plastic infusion bags.

The mold was discovered in five bags of magnesium sulfate 2GM in Dextrose 5% in water, 50ml for injection, a product used for magnesium electrolyte replacement. If an intravenous product found to contain mold is injected into a patient, it could have deadly results.

In an abundance of caution, Med Prep Consulting has recalled all products compounded by the pharmacy due to lack of sterility assurance. The affected products are administered for a wide range of therapeutic uses to hospitalized inpatients and outpatients, and patients directly treated by a health care professional at a physician’s office practice facility or clinic. None of these products is dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration.

All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials. Products packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut and Delaware. Products packaged in plastic syringes only were distributed nationwide to physician’s office practice facilities.

The discovery of contaminated compounded drugs is an eerie reminder of the multi-state fungal meningitis outbreak resulting from contaminated steroid shots manufactured by New England Compounding Center (NECC), based in Massachusetts. Investigators discovered that three lots – or about 18,000 injections – of steroid shots used to treat back or joint pain were contaminated with fungus.

An estimated 14,000 people were exposed to the tainted shots between late May and late September. To date, 722 people across 20 states have developed fungal infections including rare fungal meningitis, and 50 people have died. The Centers for Disease Control and Prevention (CDC) is still reporting new infections and deaths associated with the steroid shots.

NECC issued a recall of the steroid injections and later issued a recall of all its products. The pharmacy has since closed and its owners have filed for Chapter 11 bankruptcy.

In 1998, compounding pharmacies were exempted from U.S. Food and Drug Administration (FDA) oversight by Congress. Compounding pharmacies use drug ingredients that are approved by the FDA, but the drug cocktails these pharmacies manufacture are overseen by state pharmacy boards. By law, compounding pharmacies are not allowed to manufacture pharmaceuticals for the mass market.

In a report on the news program 60 Minutes, Dr. Margaret Hamburg, current FDA commissioner said because of the 1998 law deregulating compounding pharmacies, the FDA currently has no record of how many compounding pharmacies are in operation, or what products they are making. She says the FDA as a result cannot guarantee the safety of drugs in the United States. Often, neither patients nor physicians realize a drug came from a compounding pharmacy not regulated by the FDA.

Sources:
FDA
CDC
60 Minutes