A compounding pharmacy has issued a nationwide voluntary recall of all of its products after mold was discovered in one of its intravenous solutions. To date, no injuries or illnesses have been reported in association with the contaminated product: magnesium sulfate 2 g in dextrose 5% in water, 50 mL for injection.
The compounding pharmacy, Med Prep Consulting Inc., announced in a statement that it has voluntarily recalled all lots of all products compounded at its facility after clinicians at a Connecticut hospital notified the company that visible particulate contaminants were observed in five 50-mL bags of the product. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital, according to the company.
The contaminants were subsequently confirmed to be mold; the pharmacy then decided to voluntarily recall all of its compounded products because of lack of sterility assurance.
Injectable steroids contaminated with mold and produced by a different compounding pharmacy were discovered last October and resulted in numerous infections and deaths nationwide. The issue also was part of a recent Institute of Medicine report on drug quality concerns.
Products produced by Med Prep Consulting are used for a wide range of therapeutic purposes in hospitals, outpatient facilities, and physicians’ offices. None are dispensed directly to patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes, or glass vials.
Recalled products packaged in plastic infusion bags, plastic infusion devices, plastic syringes, and glass vials were distributed directly to regional hospital pharmacies in New Jersey, Pennsylvania, Connecticut, and Delaware.
Recalled products packaged in plastic syringes were distributed nationwide to physician office practice facilities and clinics. All of these products were distributed through March 17, 2013, from Tinton Falls, N.J., to both regional and nationwide locations.
All recipients of products compounded by Med Prep Consulting have been notified by telephone, fax, e-mail, and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390. The company has asked that product complaints related to this recall be reported to the same number.
Adverse events that may be related to the use of these products should be reported to FDA’s MedWatch Adverse Event Reporting Program.
