Remember the deadly fungal meningitis outbreak last fall linked to a New England compounding pharmacy? 50 people have died from it so far, and more than 700 have been sickened by the fungal contamination.
Well, the FDA just announced that danger of another fungal contamination in drugs has been discovered. This one has been linked to a 20-year-old compounding pharmacy based in Tinton, NJ named Med Prep Consulting Inc.
Med Prep Consulting Inc. Linked to Latest Mold Contamination Recall
The contamination was found in bags of a magnesium sulfate intravenous solution at a Connecticut hospital. The Pearland, TX drug recall attorneys at Denena Points, PC emphasize that Med Prep so far says that no illnesses or injuries have been reported from the mold contamination. But administration of mold-contaminated intravenous products could lead to fatal infections in patients receiving the products. A recall has been issued for all Med Prep products distributed between February 18th and March 15th.
FDA Recalls ALL Med Prep Products due to Sterility Concerns at Manufacturing Facility
The Director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, stated that “a lack of sterility assurance” at Med Prep, along with caution, makes the FDA recall for all of Med Prep’s products necessary in order to protect patients. Lack of sterility assurance implies that Med Prep’s facility may be affected by the same widespread, visible mold and fungus contamination that was found throughout the New England Compounding Center facility last year, including in its autoclaves.
And our Pearland, TX drug recall attorneys point out that FDA records show that the agency previously warned Med Prep in 2001 and 2010 regarding sterility problems in certain repackaged drugs. In repackaging and compounding operations, the company uses ingredients from other large manufacturers. The FDA is working with the CDC and state authorities in Connecticut and New Jersey to get a handle on the scope of the new mold contamination outbreak.
Med Prep Temporarily Halting Production as a Precaution
Med Prep has entered into an Interim Voluntary Consent Order with the New Jersey State Board of Pharmacy to halt all production and distribution of its drugs during the investigation. Our Pearland, TX drug recall attorneys note that Med Prep makes anesthetics, antibiotics, cardiac medications, pain management drugs, and labor and delivery medications. The products come packaged in glass vials, plastic syringes, and infusion bags.
The recall and production stoppage at Med Prep comes just as the FDA has begun stepping up its inspections of drug compounding pharmacies in 12 states. Last year’s deadly fungal meningitis outbreak has prompted concerned lawmakers and others to call for improved oversight of drug compounding pharmacies. Clearly, that oversight, particularly regarding the maintenance of adequate sterility at facilities used to make sensitive medications, is needed.
Learn What You can do if a Contaminated Drug has Harmed You or Your Loved One
Click on this article by our Pearland, TX drug recall attorneys. And don’t hestiate to contact us if you need help after your drug injury. Reach us at 281-369-4363 or through our online contact form.