Thursday, August 21, 2014
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N.J. compounding pharmacy recalls all products because of fear of mold contamination

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."

N.J. compounding pharmacy recalls all products because of fear of mold contamination

File photo:  (AP Photo/Press-Register, Mary Hattler)
File photo: (AP Photo/Press-Register, Mary Hattler)

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:

Acetylcystiene vials

Alteplase syringe

Atropine syringe

Avastin syringe

Aztreonam syringe

Bacitracin vials

Bupivacaine Bag

Bupivacaine Syringe

Bupivacaine OnQ Pump

Calcium Gluconate Bag

Calcium Gluconate syringe

Cefazolin syringe

Cefazolin Bag

Cefepime syringe

Cefepime Bag

Cefotaxime syringe

Cefotetan syringe

Cefoxitin syringe

Ceftazidime syringe

Ceftazidime Bag

Ceftriaxone syringe

Ceftriaxone Bag

Cefuroxime syringe

Cefuroxime Bag

Clindamycin syringe

Darboepoetin (Aranesp) syringe

Dexamethasone Bag

Diltiazem Bag

Dobutamine Bag

Dobutamine syringe

Ephedrine syringes

Epinephrine Bag

Epinephrine Bag

Epinephrine syringe

Epoetin Alfa syringe

Esmolol syringes

Famotidine syringe

Fentanyl Citrate Bag

Fentanyl Citrate with Bupivacaine HCL Bag

Gentamicin syringe

Gentamicin Bag

Glycopyrrolate syringes

Granisetron syringe

Hectoral syringe

Heparin syringe

Heparin bag

Hydromorphone syringe

Hydromorphone Bag

Hydromorphone PCA syringe

LET Gel syringe

LET Soln syringe

Leukine syringe

Magnesium Sulfate bag

Meperidine Bag

Midazolam Bag

Midazolam syringe

Morphine Sulfate Bag

Morphine Sulfate syringe

Norepinephrine bag

Norepinephrine Syringe

Ondansetron Bag

Ondansetron syringe

Oxacillin syringe

Oxacillin Bag

Oxytocin bag

Palanosetron (Aloxi) syringe

Penicillin syringe

Penicillin Bag

Phenylephrine Bags

Phenylephrine syringes

Potassium Chloride Bag

Potassium Phosphate l bag

Ranitidine syringe

Rituxan syringe

Ropivacaine Bag

Ropivacaine OnQ Pump

Sodium Citrate syringe

Sodium Phosphate bag

Succinylcholine syringes

Sufentanil with Bupivacaine Bag

Timentin syringe

Tobramycin syringe

Zometa syringe

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell
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