Monday 18 March 2013

Compounded Products Recall: Potential Mold Contamination

A special report by Tim Sandle.

A New Jersey compounding pharmacy has temporarily shut down its operations after Connecticut hospital officials reported finding visible mold in bags of an injection drug.

The U.S. Food and Drug Administration (FDA) has announced that Med Prep Consulting, Inc.  is recalling all lots of all products compounded at its facility, due to lack of sterility assurance (see the end of this article for a list of the products being recalled). The move followed a voluntary consent order enacted Friday that will remain in effect until at least March 22.

The level of recall is to the user: 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. The affected 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. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials.

To date, no injuries or illnesses have been reported. According to NBC News, New Jersey Health Commissioner Mary E. O'Dowd said in response to the incident: "This investigation is evolving. At this time, in an abundance of caution, the Department of Health recommends that any health care facility that has received products from Med Prep should inventory them and remove them from use."

Med Prep is a specialty intravenous I.V. pharmacy licensed by the State of New Jersey offering sterile compounding services. In operation since 1994. There was no word of the recall via a search of the company web site.

This incident follows on from the fungal contamination found in three lots of medication used for epidural steroid injections, which was packaged and marketed by the New England Compounding Center (NECC), a compounding pharmacy in Framingham, Massachusetts.

Compounding pharmacies are authorized, in the U.S., to combine, mix or alter ingredients to create specific formulations of drugs to meet the specific needs of individual patients, and only in response to individual prescriptions.

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.
Other recent compounding pharmacy issues, where there have been contamination concerns, are, as noted by the New York Times and USA Today:

a) In August 2011, the FDA reported that repackaged injections of Avastin (bevacizumab) caused serious eye infections in the Miami, Florida area. A pharmacy had repackaged the Avastin from single-use vials into multiple single-use syringes, distributing them to multiple eye clinics, and infecting at least 12 patients. Some patients lost the remaining vision in the eye being treated.

b) From November 2011 to April 2012, 33 eye-surgery patients in seven states suffered a rare fungal eye infection tied to injectable drug products made by a compounding pharmacy in Ocala, Florida. Most of those patients suffered partial to severe vision loss.

c) In November 13 2012, it was reported that manufacturing problems were found at Ameridose, a Massachusetts company that makes injectable drugs.

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
Posted by Tim Sandle

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