FDA Alert: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination
This is a reprint of an FDA Alert
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:
Acetylcystiene vials Adenosine Bags
Alteplase syringe Atropine syringe
Avastin syringe Aztreonam syringe Bacitracin vials
Bupivacaine Bag Bupivacaine Epinephrine 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
Denusumab Syringe Dexamethasone Bag Diltiazem Bag
Diphenhydramine Bags 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
Methadone Syringe Midazolam Bag Midazolam syringe
Morphine Sulfate Bag Morphine Sulfate syringe Norepinephrine bag
Norepinephrine Syringe Ondansetron Bag Ondansetron – Dexamethasone 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
Vancomycin Bags Zometa syringe
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
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