Posted by Salvatore J. Zambri, founding member and partner
A recent U.S. Food and Drug Administration (FDA) press release announced the voluntary recall of all compounded products by Medprep Consulting, Inc. due to potential mold contamination. We are including the complete FDA press release along with a listing of all the products in the recall.
“Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Contact Consumer: 732-493-3390
Media: Angelo J. Cifaldi, Esq., R.Ph. Satish V. Poondi, Esq., R.Ph. Counsel for Med Prep Consulting Inc. (732)855-6096
FOR IMMEDIATE RELEASE – March 17, 2013 – Tinton Falls, NJ., Med Prep Consulting, Inc. is voluntarily recalling all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. In an abundance of caution, the pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance.
Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in a broad array of patients. To date, no injuries or illnesses have been reported.
The products are used for a wide range of therapeutic uses for 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 are 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 and clinics. All of these products were distributed to the described users through March 13, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.
Included in the recall are the following product list:
All facilities that received any product compounded by Med Prep Consulting, Inc. have been notified by telephone fax, electronic 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, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.
Product complaints related to this recall should be reported to 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.
Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.
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About the author:
Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the ” 2011 Trial Lawyer of the Year“. He has also been acknowledged by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as “one of Washington’s best–most honest and effective lawyers” who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2013 edition) acknowledged as one of the “Best Lawyers in America” by Best Lawyers in both medical malpractice and personal injury law, and has also been repeatedly named a “Super Lawyer” by Law and Politics magazine (2013)–a national publication that honors the top lawyers in the country.
Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.
If you have any questions about your legal rights, please email Mr. Zambri at [email protected]. You may also reach him at 202-822-1899.