New Jersey-based compounding pharmacy Med Prep Consulting Inc., announced that a "nationwide recall of all lots of all compounded products due to potential mold contamination."
The company is located in Tinton Falls, Monmouth County.
There was no word of the recall via a search of the company web site.
The U.S. Food and Drug Administration posted the company's announcement, with a note in red letters at the top saying the agency does not endorse any of the statement.
This episode follows the outbreak of meningitis that was caused by tainted products from a Boston-area compounding pharmacy.
There is debate among governments and regulators about which agency has primary oversight of compounding pharmacy. The FDA says it has less power to overseas compounding pharmacies than it does traditional manufacturers of pharmaceuticals. State governments have clung to the power to regulate pharmacies of all kinds.
A link to the FDA posting on Med Prep Consulting Inc., is here.
"The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices," the statement said. "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 (all caps in the statement) 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."
Med Prep Consulting says the company was founded in 1994. The company site is here.
"The company also offers medications for specific uses, including antibiotics, sedatives, pain management medications, cardiac medicines, antiemetics, anticoagulants, anesthetics, electrolyte solutions, and a variety of other medications," a company description says on its web site. "The company compounds the formulation according to the client’s wishes, which gives the client more freedom when it comes to ordering products. The client can now store much smaller amounts of each formulation, which eliminates the waste of expired drug and therefore lowers costs. Med Prep has been serving pharmacies, doctor’s offices, and hospitals since 1994."
Here is the list of all of Med Prep Consulting's products, all of which are being recalled:
Bupivacaine OnQ Pump
Calcium Gluconate Bag
Calcium Gluconate syringe
Darboepoetin (Aranesp) syringe
Epoetin Alfa syringe
Fentanyl Citrate Bag
Fentanyl Citrate with Bupivacaine HCL Bag
Hydromorphone PCA syringe
LET Gel syringe
LET Soln syringe
Magnesium Sulfate bag
Morphine Sulfate Bag
Morphine Sulfate syringe
Palanosetron (Aloxi) syringe
Potassium Chloride Bag
Potassium Phosphate l bag
Ropivacaine OnQ Pump
Sodium Citrate syringe
Sodium Phosphate bag
Sufentanil with Bupivacaine Bag