FDA: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination

[Catbird]

Although only 1 lot of one specific product has been shown to be contaminated so far, ALL products made by this compounding pharmacy are being recalled.

FDA announcement:

Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination



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.

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:

Online: www.fda.gov/medwatch/report.htm disclaimer icon
Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178


Med Prep Consulting Product List

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

[Missouriwatcher]

Re: FDA: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination

March 20, 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 17, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.

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.

http://www.fda.gov/Safety/Recalls/ucm344787.htm