Compounding Pharmacy Issues Recall

Following the discovery of mold within sealed packages of an intravenous solution packaged in plastic and glass containers, Med Prep Consulting, Inc. has issued a recall of a large number of its products produced and packaged at its Tinton Falls, New Jersey facility. The discovery of visible contaminants was made at a Connecticut hospital in five bags of Magnesium Sulfate 2GM in Dextrose 5% in water, 50ML for injection-sealed bags. After testing was completed on the solution, the contaminants were determined to be mold, which called into question the sterility of the Med Prep packaging and production facility.

In conjunction with the U.S. Food and Drug Administration (FDA), Med Prep has issued a wide-range recall on a number of products produced at Tinton Falls, New Jersey. These products include those packaged in plastic bags, syringes and glass vials that could possibly be contaminated and lead to a potentially dangerous infection for patients. To this point, no infections or adverse reactions have been reported by medical facilities using Med Prep products. It is reported that the batch of Magnesium Sulfate solution that has been identified as containing the contaminants were shipped only to hospitals in Delaware, Connecticut, New Jersey and Pennsylvania. Despite this, the company is also recalling a large number of its other products (84 in all) as a precautionary measure to reduce the possibility of contamination occurring.

None of the products so far recalled were available for retail purchase by members of the public and were instead sold directly to medical facilities, such as hospitals and doctor’s offices. The range of products which have been recalled are used by medical professionals in both inpatient and outpatient facilities. All the products thought to be possibly affected by the mold contaminants were sold to medical facilities prior to March 17, 2013 to locations across the U.S.

Med Prep Consulting, Inc. has teamed with the FDA in an attempt to broaden the knowledge of the recall to medical facilities across the U.S. and ensure any possibly contaminated products are not used. Med Prep has made its customers aware of the recall and any medical problems linked with the contamination should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

Resources

http://www.fda.gov/Safety/Recalls/ucm344787.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm344259.htm